OTC Medication Information: Childrens Robitussin Nighttime Cough Long-Acting DM

CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM- chlorpheniramine maleate and dextromethorphan hydrobromide solution
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients (in each 10 mL)

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg

Purposes

Antihistamine

Cough suppressant

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

Warnings

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

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

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.

If pregnant or breast-feeding, ask a health professional before use.

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
Age Dose

Children under 6 years

do not use

children 6 to under 12 years

10 mL every 6 hours

adults and children 12 years and older

20 mL every 6 hours

Other information

each 10 mL contains: sodium 6 mg
store at 20-25°C (68-77°F)

Inactive ingredients

anhydrous citric acid, artificial & natural flavors, FD&C red no. 40, glycerin, lactic acid, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

call weekdays from 9 AM to 5 PM EST at 1-800-245-1040

Additional Information

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

Children’s Robitussin liquid is specially formulated to provide soothing action, control your child’s cough plus relieve other cold symptoms.

Should be 18 or older to purchase

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Use dosage cup included

Distributed by: GSK Consumer Healthcare,

Warren, NJ 07059

For most recent product information,

visit www.robitussin.com

Trademarks owned or licensed by GSK.

©2022 GSK or licensor

Made in Canada

Principal Display Panel

Children’s

Robitussin

AGES 6 & OVER

Nighttime
Cough

Long-Acting

DM

CHLORPHENIRAMINE MALEATE (Antihistamine)
DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves Cough up to 8 Hours
Runny Nose

Alcohol-Free

Fruit punch flavor

4 FL OZ (118 mL)

PAA172103 Front Carton

Robitussin Ch NT CC LA 4 oz(118 mL)
(click image for full-size original)
CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM
chlorpheniramine maleate, dextromethorphan hydrobromide solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8692
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 2 mg in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
GLYCERIN
LACTIC ACID, UNSPECIFIED FORM
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM CITRATE, UNSPECIFIED FORM
SORBITOL
SUCRALOSE
Product Characteristics
Color RED (red) Score
Shape Size
Flavor FRUIT PUNCH Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0031-8692-13 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (0031-8692-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/01/2014
Labeler — GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 06/2022 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2023. All Rights Reserved.