Active Ingredients (In Each 20 Ml)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Robitussin Maximum Strength Severe Multi-symptom Cough Cold Flu Nighttime (NDC 0031-0101). 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 650 mg
Diphenhydramine HCl 25 mg
Pain reliever/Fever reducer
Antihistamine/Cough suppressant
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.
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
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, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
Questions or comments?
call weekdays from 8 AM to 6 PM EST at 1-800-245-1040
Do Not Use if breakable ring on bottle cap is separated or missing.
ADULT
Robitussin
MAXIMUM STRENGTH
SEVERE MULTI-SYMPTOM
Cough Cold + Flu CFNIGHTTIME MAX
Distributed by: Haleon, Warren, NJ 07059
For most recent product information, visit www.robitussin.com
Trademarks owned or licensed by Haleon.
Pat. Info www.productpats.com
©2023 Haleon or licensor. Made in Canada
ADULT NEW FORMULA HALEON
Robitussin
MAXIMUM STRENGTH
SEVERE
MULTI-SYMPTOM
Cough Cold + Flu
Nighttime
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
Relieves Cough to Help You Rest
✓Cough, Sore Throat
✓Head & Body Aches, Fever
✓Runny Nose, Sneezing
FAST, POWERFUL
multi-symptom relief
CF
NIGHTTIME
MAX
For Ages 12 & Over
4 FL OZ (237 mL)
207723 Front Carton
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