FDA Label for Robitussin Maximum Strength Severe Multi-symptom Cough Cold Flu Nighttime

View Indications, Usage & Precautions

Robitussin Maximum Strength Severe Multi-symptom Cough Cold Flu Nighttime Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. 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.

Active Ingredients (In Each 20 Ml)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Purposes

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

Indications & Usage

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

Warnings

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

Other

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

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.
with any other drug containing diphenhydramine, even one used on skin

Otc - Ask Doctor

Ask a doctor before use if you have

liver disease
trouble urinating due to an enlarged prostate gland
glaucoma
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)

Otc - Ask Doctor/Pharmacist

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

When Using This Product

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

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 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 health professional before use.

Otc - Keep Out Of Reach Of Children

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.

Dosage & Administration

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

Storage And Handling

Other information

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

Inactive Ingredient

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

Otc - Questions

Questions or comments?

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

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

Principal Display Panel

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

* Please review the disclaimer below.

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