Adult Dosing & Uses
Dosing Forms & Strengths
acetaminophen/guaifenesintablet
325mg/200mg
capsule
325mg/200mg
oral solution
(500mg/200mg)/15mL
packet
1000mg/400mg
325mg/200mg
capsule
325mg/200mg
oral solution
(500mg/200mg)/15mL
packet
1000mg/400mg
Cough, Fever, Headache, Minor Aches & Pains
Theraflu Flu & Chest Congestion: 1 packet dissolved in 8 oz of hot water q6hr; not to exceed 4 packets/day; consume entire drink within 10-15 minutes
Tylenol Chest Congestion: 2 capsules PO q4–6hr; not to exceed 12 capsules/day
Tylenol Chest Congestion: 2 capsules PO q4–6hr; not to exceed 12 capsules/day
Pediatric Dosing & Uses
Dosing Forms & Strengths
acetaminophen/guaifenesin
tablet
325mg/200mg
capsule
325mg/200mg
oral solution
(500mg/200mg)/15mL
packet
1000mg/400mg
tablet
325mg/200mg
capsule
325mg/200mg
oral solution
(500mg/200mg)/15mL
packet
1000mg/400mg
Cough, Fever, Headache, Minor Aches & Pains
Theraflu Flu & Chest Congestion
<12 years old: Ask a pediatrician
>12 years old: 1 packet dissolved in 8 oz of hot water q6hr; not to exceed 4 packets/day; consume entire drink within 10-15 minutes
Tylenol Chest Congestion
<12 years old: Ask a pediatrician
>12 years old: 2 capsules PO q4–6hr; not to exceed 12 capsules/day
<12 years old: Ask a pediatrician
>12 years old: 1 packet dissolved in 8 oz of hot water q6hr; not to exceed 4 packets/day; consume entire drink within 10-15 minutes
Tylenol Chest Congestion
<12 years old: Ask a pediatrician
>12 years old: 2 capsules PO q4–6hr; not to exceed 12 capsules/day
Pharmacology
Mechanism of Action
Acetaminophen: blocks pain impulse generation peripherally & may inhibit the generation of prostaglandin in the CNS; reduces fever by inhibiting the hypothalamic heat-regulating center
Guaifenesin: increases respiratory tract fluid secretions & helps to loosen phlegm & bronchial secretions
Guaifenesin: increases respiratory tract fluid secretions & helps to loosen phlegm & bronchial secretions
Adverse Effects
Dizziness
Drowsiness
Headache
Dermatologic rash
Nausea
Vomiting
Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)
Bilirubin and alkaline phosphatase may increase
Drowsiness
Headache
Dermatologic rash
Nausea
Vomiting
Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)
Bilirubin and alkaline phosphatase may increase
Drug Interactions
Contraindications & Cautions
Contraindications
Hypersensitivity
G-6-PD deficiency
Severe hepatic impairment
G-6-PD deficiency
Severe hepatic impairment
Cautions
Acetaminophen hepatotoxicity possible in chronic alcoholics following various dose levels; severe or recurrent pain or high or continued fever may indicate a serious illness; contained in many OTC products and combined use with these products may result in toxicity due to cumulative doses exceeding recommended maximum dose
Guaifenesin is not for administration in persistent cough associated with chronic bronchitis, smoking, asthma, or accompanied with excessive secretions
Guaifenesin is not for administration in persistent cough associated with chronic bronchitis, smoking, asthma, or accompanied with excessive secretions
Patient Handout
Patient Education
acetaminophen-guaifenesin Oral
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
EXPECTORANT/ACETAMINOPHEN - ORAL
USES:
This combination medication is used to temporarily treat symptoms caused by the common cold, flu, allergies, or other breathing illnesses (such as sinusitis, bronchitis). The expectorant helps thin and loosen mucus in the lungs, making it easier to cough up the mucus. Acetaminophen (APAP) is a non-aspirin pain reliever and fever reducer.
This medication is not usually used for ongoing coughs from smoking, asthma, other long-term breathing problems (such as emphysema), or coughs with a lot of mucus unless directed by your doctor.
Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.
These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).
HOW TO USE:
Read and follow all directions on the package label. If you have any questions, consult your pharmacist.
Take this medication by mouth with or without food, usually every 4 to 6 hours as needed, or as directed by your doctor. Drink plenty of fluids when you use this medication unless otherwise directed by your doctor. The fluid will help loosen the mucus in your lungs.
If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. If your liquid form is a suspension, shake the bottle well before each dose.
The dosage is based on your age, medical condition, and response to treatment. Do not increase your dose, take it more frequently, or use it for a longer time than directed. Do not give children medicines labeled only for adults.
One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4 grams (4000 milligrams) of acetaminophen a day. A smaller dose should be used in children and in people with liver disease. Read the product package or consult your doctor. Carefully check the labels of all your medicines (such as pain/fever drugs or cough-and-cold products) to make sure they do not also contain acetaminophen. (See also Side Effects section.)
Tell your doctor if your condition persists for more than 1 week, if it worsens, or if it occurs with rash, persistent headache, or fever lasting more than 3 days. These may be symptoms of a serious medical problem and should be checked by a doctor.
SIDE EFFECTS:
Upset stomach or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Taking more than the recommended dose of acetaminophen may cause serious (possibly fatal) liver disease. Seek immediate medical attention if you have any of the following symptoms of liver damage: dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS:
Before taking this product, tell your doctor or pharmacist if you are allergic to any of its ingredients; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
If you have any of the following health problems, consult your doctor or pharmacist before using this medication: breathing problems (such as asthma, emphysema), liver disease.
Acetaminophen may cause liver damage. Daily use of alcohol and acetaminophen may increase your risk. Avoid alcoholic beverages.
Some brands of this product may contain sugar, alcohol, or aspartame. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication may pass into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS:
If you are taking this product under your doctor's direction, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
The ingredients in this product are available in many prescription and nonprescription products. Check the labels on all your medicines (such as pain/fever drugs or cold/allergy products) because they may contain the same or similar ingredients. Ask your pharmacist about using those products safely. (See also How to Use section.)
This medication may interfere with certain laboratory tests (including urine 5-HIAA), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE:
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: persistent nausea/vomiting, dark urine, stomach/abdominal pain.
NOTES:
Keep all regular medical and laboratory appointments.
MISSED DOSE:
If you are taking this product on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE:
Store in a tightly closed container at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Do not freeze liquid forms of this medication. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised January 2011 Copyright(c) 2011 First DataBank, Inc.
acetaminophen-guaifenesin Oral
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
EXPECTORANT/ACETAMINOPHEN - ORAL
USES:
This combination medication is used to temporarily treat symptoms caused by the common cold, flu, allergies, or other breathing illnesses (such as sinusitis, bronchitis). The expectorant helps thin and loosen mucus in the lungs, making it easier to cough up the mucus. Acetaminophen (APAP) is a non-aspirin pain reliever and fever reducer.
This medication is not usually used for ongoing coughs from smoking, asthma, other long-term breathing problems (such as emphysema), or coughs with a lot of mucus unless directed by your doctor.
Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.
These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).
HOW TO USE:
Read and follow all directions on the package label. If you have any questions, consult your pharmacist.
Take this medication by mouth with or without food, usually every 4 to 6 hours as needed, or as directed by your doctor. Drink plenty of fluids when you use this medication unless otherwise directed by your doctor. The fluid will help loosen the mucus in your lungs.
If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. If your liquid form is a suspension, shake the bottle well before each dose.
The dosage is based on your age, medical condition, and response to treatment. Do not increase your dose, take it more frequently, or use it for a longer time than directed. Do not give children medicines labeled only for adults.
One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4 grams (4000 milligrams) of acetaminophen a day. A smaller dose should be used in children and in people with liver disease. Read the product package or consult your doctor. Carefully check the labels of all your medicines (such as pain/fever drugs or cough-and-cold products) to make sure they do not also contain acetaminophen. (See also Side Effects section.)
Tell your doctor if your condition persists for more than 1 week, if it worsens, or if it occurs with rash, persistent headache, or fever lasting more than 3 days. These may be symptoms of a serious medical problem and should be checked by a doctor.
SIDE EFFECTS:
Upset stomach or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Taking more than the recommended dose of acetaminophen may cause serious (possibly fatal) liver disease. Seek immediate medical attention if you have any of the following symptoms of liver damage: dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS:
Before taking this product, tell your doctor or pharmacist if you are allergic to any of its ingredients; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
If you have any of the following health problems, consult your doctor or pharmacist before using this medication: breathing problems (such as asthma, emphysema), liver disease.
Acetaminophen may cause liver damage. Daily use of alcohol and acetaminophen may increase your risk. Avoid alcoholic beverages.
Some brands of this product may contain sugar, alcohol, or aspartame. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication may pass into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS:
If you are taking this product under your doctor's direction, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
The ingredients in this product are available in many prescription and nonprescription products. Check the labels on all your medicines (such as pain/fever drugs or cold/allergy products) because they may contain the same or similar ingredients. Ask your pharmacist about using those products safely. (See also How to Use section.)
This medication may interfere with certain laboratory tests (including urine 5-HIAA), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE:
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: persistent nausea/vomiting, dark urine, stomach/abdominal pain.
NOTES:
Keep all regular medical and laboratory appointments.
MISSED DOSE:
If you are taking this product on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE:
Store in a tightly closed container at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Do not freeze liquid forms of this medication. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised January 2011 Copyright(c) 2011 First DataBank, Inc.
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