Active Ingredients (In Each 20 Ml)
Acetaminophen, USP 650 mg
Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 400 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Pharmacy (NDC 51316-089). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 20 ml), purposes, indications & usage, warnings, liver warning, other, sore throat warning, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen, USP 650 mg
Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 400 mg
Pain reliever/Fever reducer
Cough suppressant
Expectorant
Uses
Warnings
This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Distributed by:
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.
Do not use
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
When using this product do not use more than directed
Stop use and ask a doctor if
If pregnant or breast-feeding,ask a health professional before use.
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Directions
| age | dose |
|---|---|
adults and children 12 years and over | 20 ml every 4 hours |
children under 12 years | do not use |
Other information
Inactive ingredients
anhydrous citric acid, edetate disodium, FD&C red no. 40, glycerin, menthol, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
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Compare to the active ingredients in Adult Robitussin® Maximum Strength SEVERE Multi-Symptom Cough Cold + Flu CF MAX*
NDC 51316-089-08
MAXIMUM STRENGTH
Adult
SEVERE
Multi-Symptom
Cough Cold + Flu
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)
Sugar-Free
No Added Alcohol
Natural Raspberry Flavor
For Ages 12 & Over
8 FL OZ (237 ml)
IMPORTANT: Keep this carton for future reference for full labeling
TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING
*This product is not manufactured or distributed by GSK Consumer Healthcare, Owner o the registered trademark Adult Robitussin Maximum Strength SEVERE Multi-Symptom Cough Cold + Flu CF MAX.
* Please review the disclaimer below.