FDA Label for Robitussin Maximum Strength Severe Multi-symptom 7 In 1 Relief Nighttime

View Indications, Usage & Precautions

Robitussin Maximum Strength Severe Multi-symptom 7 In 1 Relief 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.

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

Otc - Purpose

Active ingredients (in each liquid-filled capsule)	Purposes
Acetaminophen, USP 325 mg	Pain reliever/Fever reducer
Dextromethorphan HBr, USP 15 mg	Cough suppressant
Doxylamine Succinate, USP 6.25 mg	Antihistamine

Indications & Usage

Uses

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

Warnings

Liver Warning

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

more than 8 capsules 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

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.

Do Not Use

to sedate a child or to make a child sleepy
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask A Doctor Before Use If You Have

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

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

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
cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
new symptoms occur

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 8 capsules in any 24-hour period
do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	2 capsules every 6 hours
children under 12 years	do not use

Storage And Handling

Other information

store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).

Inactive Ingredient

Inactive ingredients

D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Otc - Questions

Questions or comments?

Call weekdays from 9 AM to 5 PM EST at 1 800-762-4675

Principal Display Panel - 325 Mg/15 Mg/6.25 Mg Capsule Blister Pack

Robitussin^®
Maximum Strength
Severe Multi-Symptom
7 in 1 Relief Nighttime

Each liquid-filled capsule contains:
Acetaminophen, USP 325 mg
Dextromethorphan HBr, USP 15 mg
Doxylamine Succinate, USP 6.25 mg
See warnings before use.
Dist. by Pfizer,
Madison, NJ 07940 USA
Made in Canada

TEAR AT NOTCH

PAA102379
P12132

Principal Display Panel - 10 Capsule Blister Pack Carton

ADULT

Robitussin^®

MAXIMUM
STRENGTH

SEVERE
Multi-Symptom
7 in 1 Relief

ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DEXTROMETHORPHAN HBr (Cough Suppressant)
DOXYLAMINE SUCCINATE (Antihistamine)

CF
NIGHTTIME
MAX

✓Cough, Sore Throat
✓Body Aches, Fever
✓Runny Nose, Sneezing
✓Itchy Throat

For Ages 12 & Over

10
LIQUID-FILLED
CAPSULES

* Please review the disclaimer below.

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