FDA Label for Robitussin Sugar-free Dye-free Cough Plus Chest Congestion Dm

View Indications, Usage & Precautions

OTHER
OTC - PURPOSE
INDICATIONS & USAGE
WARNINGS
OTC - DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE
OTC - STOP USE
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
STORAGE AND HANDLING
INACTIVE INGREDIENT
OTC - QUESTIONS
PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL
PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON

Robitussin Sugar-free Dye-free Cough Plus Chest Congestion Dm 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

Distributed by:
Pfizer, Madison, NJ 07940 USA

Otc - Purpose

Active ingredients (in each 20 ml)	Purposes
Dextromethorphan HBr, USP 20 mg	Cough suppressant
Guaifenesin, USP 200 mg	Expectorant

Indications & Usage

Uses

•temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
•helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

Otc - Do Not Use

Do not use 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.

Ask A Doctor Before Use If You Have

•cough that occurs with too much phlegm (mucus)
•cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Otc - Stop Use

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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.

Dosage & Administration

Directions

•do not take more than 6 doses in any 24-hour period
•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

Storage And Handling

Other information

•each 20 ml contains: sodium 20 mg
•store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredient

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, glycerin, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, triacetin, xanthan gum

Otc - Questions

Questions or comments?

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

Principal Display Panel - 118 Ml Bottle Label

ADULT

Robitussin^®

SUGAR-FREE
DYE-FREE

Cough+Chest
Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

Non-Drowsy

4 FL OZ (118 ml)

Principal Display Panel - 118 ml Bottle Label - robitussin 01

Principal Display Panel - 118 Ml Bottle Carton