Other
Drug Facts
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.
Distributed by: Pfizer, Madison, NJ 07940 USA
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Robitussin Severe Multi-symptom Cough Cold Flu (NDC 0031-8751). 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 other, otc - purpose, indications & usage, warnings, liver warning, sore throat warning, otc - do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
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: Pfizer, Madison, NJ 07940 USA
| Active ingredients (in each 20 ml) | Purposes |
|---|---|
| Acetaminophen, USP 650 mg | Pain reliever/Fever reducer |
| Dextromethorphan HBr, USP 20 mg | Cough suppressant |
| Guaifenesin, USP 400 mg | Expectorant |
| Phenylephrine HCl, USP 10 mg | Nasal decongestant |
Uses
Warnings
This product contains acetaminophen. Severe liver damage may occur if you take
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. 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, natural and artificial flavors, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, triacetin, xanthan gum
Questions or comments?
call weekdays from 9 AM to 5 PM EST at 1-800-762-4675
Made in Canada
For most recent product information, visit www.robitussin.com
ADULT
Robitussin®
MAXIMUM STRENGTH
SEVERE
Multi-Symptom
Cough Cold + Flu
CF
MAX
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
PHENYLEPHRINE HCl (Nasal Decongestant)
4 FL OZ (118 ml)
ADULT
NEW!
Robitussin®
MAXIMUM STRENGTH
SEVERE
Multi-Symptom
Cough Cold + Flu
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
PHENYLEPHRINE HCl (Nasal Decongestant)
Relieves:
✓Cough, Sore Throat
✓Body Aches, Fever
✓Nasal Congestion
✓Chest Congestion
Non-Drowsy
Better Taste!
Treats More
Symptoms*
CF
MAX
For Ages 12 & Over
4 FL OZ (118 ml)
* Please review the disclaimer below.