FDA Label for Acetaminophen, Dextromethorphan Hbr, Chlorpheniramine Maleate
View Indications, Usage & Precautions
Acetaminophen, Dextromethorphan Hbr, Chlorpheniramine Maleate Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredients (in each packet)
Acetaminophen 1000 mg
Dextromethorphan HBr 30 mg
Active ingredients (in each packet)
Acetaminophen 1000 mg
Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg
Otc - Purpose
Purposes
Pain reliever/fever reducer
Cough suppressant
Purposes
Pain reliever/Fever reducer
Antihistamine
Cough suppressant
Uses
• temporarily relieves these symptoms due to a common cold or flu:
• minor aches and pains • minor sore throat pain • headache
• cough due to minor throat and bronchial irritation
• temporarily reduces fever
• temporarily relieves these symptoms due to a common cold or flu:
• minor aches and pains • minor sore throat pain
• headache • runny nose • cough due to minor throat and bronchial irritation
• temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
• skin reddening • blisters • rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
• skin reddening • blisters • rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly
Otc - Do Not Use
• in a child under 12 years of age
• if you are allergic to acetaminophen
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Do not use
• in a child under 12 years of age
• if you are allergic to acetaminophen
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Otc - Ask Doctor
Ask a doctor before use if you have
• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask a doctor before use if you have
• liver disease
• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
• cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
Ask a doctor or pharmacist before use if you are
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin
Otc - When Using
When using this product do not use more than directed.
When using this product
•
do not exceed recommended dosage
• avoid alcoholic drinks
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children
Otc - Stop Use
Stop use and ask a doctor if
• pain or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with a rash or headache that lasts
These could be signs of a serious condition.
Stop use and ask a doctor if
• pain or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with a rash or headache that lasts
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a doctor before use.
If pregnant or breast-feeding, ask a doctor before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is
critical for adults as well as for children even if you do not notice any signs or symptoms.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
• do not use more than directed
• take every 6 hours, while symptoms persist
• Do not take more than 4 packets in 24 hours unless directed by a doctor
• dissolve contents of one packet into 8 oz. hot water, sip while hot. Consume entire drink within 10 - 15 minutes.
• if using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat.
| Age | Dose |
| adults and children 12 years
of age and over | one packet |
| children under 12 years of age | do not use |
• do not use more than directed
• take every 6 hours, while symptoms persist
• Do not take more than 4 packets in 24 hours unless directed by a doctor
• dissolve contents of one packet into 8 oz. hot water, sip while hot. Consume entire drink within 10 - 15 minutes.
• if using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat.
| Age | Dose |
| adults and children 12 years
of age and over | one packet |
| children under 12 years of age | do not use |
Other Information
•
each packet contains: sodium 6 mg, potassium 10 mg
• Store in a dry place at 15° – 30°C (59° – 86°F).
• each packet contains: sodium 6 mg, potassium 10 mg
• Store in a dry place at 15° – 30°C (59° – 86°F).
Inactive Ingredient
acacia, acesulfame potassium, anhydrous citric acid, corn starch, D&C yellow #10, diacetyl tartaric and fatty acid esters of glycerol, FD&C blue #1, FD&C red #40, maltodextrin, medium chain triglycerides, natural flavor, propylene glycol, silicon dioxide, soy lecithin,
sucralose, sucrose, tartaric acid, triacetin, tribasic calcium phosphate, trisodium citrate dihydrate, yeast.
acacia, acesulfame potassium, anhydrous citric acid, corn starch, D&C yellow #10, diacetyl tartaric and fatty acid esters of glycerol, FD&C red #40, maltodextrin, medium chain triglycerides, natural flavor, propylene glycol, silicon dioxide, soy lecithin, sucralose, sucrose, tartaric acid, triacetin, tribasic calcium phosphate, trisodium citrate dihydrate, yeast.
Otc - Questions
Questions? 1-800-231-4670
* Please review the disclaimer below.
