FDA Label for Robitussin Honey Maximum Strength Nighttime Cough Dm

View Indications, Usage & Precautions

OTHER
OTC - PURPOSE
USES
DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE
OTC - ASK DOCTOR/PHARMACIST
WHEN USING THIS PRODUCT
OTC - STOP USE
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL
PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON

Robitussin Honey Maximum Strength Nighttime Cough 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 30 mg	Cough suppressant
Doxylamine Succinate, USP 12.5 mg	Antihistamine

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- controls the impulse to cough to help you sleep

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.

Ask A Doctor Before Use If You Have

trouble urinating due to an enlarged prostate gland
glaucoma
a 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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When Using This Product

do not use more than directed
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 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.

Directions

measure only with dosing cup provided
keep dosing cup with product
ml = milliliter
do not take more than 4 doses in any 24-hour period
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 6 hours
children under 12 years	do not use

Other Information

each 20 ml contains: sodium 21 mg
store at 20-25°C (68-77°F)

Inactive Ingredients

anhydrous citric acid, blueberry juice concentrate, carboxymethylcellulose sodium, glycerin, lactic acid, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

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^®

Honey

MAXIMUM STRENGTH

Nighttime
Cough DM

DM
NIGHTTIME
MAX

DEXTROMETHORPHAN HBr (Cough Suppressant)
DOXYLAMINE SUCCINATE (Antihistamine)

4 FL OZ (118 ml)

Principal Display Panel - 118 Ml Bottle Carton