Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime

Generic name: acetaminophen, diphenhydramine hcl

Haleon US Holdings LLC

Dosage Form

N/A

Manufacturer

Haleon US Holdings LLC

Active ingredients

ACETAMINOPHEN650 mg / 20 mL
DIPHENHYDRAMINE HYDROCHLORIDE25 mg / 20 mL

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

Uses

temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other respiratory allergies:
- cough due to minor throat and bronchial irritation
- headache
- sore throat
- minor aches and pains
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
temporarily relieves your cough to help you rest
temporarily reduces fever

marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Directions

do not take more than 6 doses in any 24-hour period
do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
measure only with dosing cup provided
keep dosing cup with product
mL = milliliter
this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	20 mL every 4 hours
children under 12 years	do not use

age

dose

adults and children

12 years and over

20 mL every 4 hours

children under 12 years

do not use

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

0031-0101-04

Full prescribing information (for healthcare professionals)

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

more than 6 doses in any 24-hour period, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

SPL UNCLASSIFIED SECTION

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.

Additional information

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

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Active ingredients

Important Safety Information

What this medicine is forThe uses this medicine is approved for.

What this medicine is forOver-the-counter use.

How to take itDosage and administration instructions.Directions do not take more than 6 doses in any 24-hour period do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. measure only with dosing cup provided keep…

Do not use if…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 si…

Ask a doctor before use if…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 rash or headach…

Ask a doctor or pharmacist before use if…Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking any other pain reliever/fever reducer taking sedatives or tranquilizers

Stop use and talk to a doctor if…Do not use to sedate a child or to make a child sleepy with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist…

Storage and handlingOther information each 20 mL contains:sodium 12 mg store at 20-25°C (68-77°F)

Package labelADULT 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 Hel…