CHILDRENS ROBITUSSIN ELDERBERRY COUGH AND CHEST CONGESTION DM- dextromethorphan hbr, guaifenesin solution

Childrens Robitussin Elderberry Cough and Chest Congestion DM by

Drug Labeling and Warnings

Childrens Robitussin Elderberry Cough and Chest Congestion DM by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purposes

Cough suppressant

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

Warnings

Do not useif 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.

Stop use and ask a doctor ifcough 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.

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

age	dose
children under 4 years	do not use
children 4 to under 6 years	5 mL every 4 hours
children 6 to under 12 years	10 mL every 4 hours
adults and children 12 years and over	20 mL every 4 hours

STORAGE AND HANDLING

Other information

• each 20 mL contains:potassium 5 mg, sodium 21 mg
• store at 20-25°C (68-77°F). Do not refrigerate.

INACTIVE INGREDIENT

Inactive ingredients

anhydrous citric acid, black elderberry juice concentrate (for flavor), carboxymethylcellulose sodium, glycerin, liquid glucose, maltodextrin, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

QUESTIONS

Questions or comments?

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

Additional information

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Packaged with Tamper-Evident bottle cap.

Do Not Use if breakable ring is separated or missing.

PRINCIPAL DISPLAY PANEL

Children’s

Robitussin

Elderberry

Cough & Chest
Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

• Controls Cough
• Relieves Chest Congestion
• Thins & Loosens Mucus

Taste the
Real Elderberry

4 FL OZ (118 mL)

For Ages 4+

INGREDIENTS AND APPEARANCE

CHILDRENS ROBITUSSIN ELDERBERRY COUGH AND CHEST CONGESTION DM 
dextromethorphan hbr, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-2098
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)

Product Characteristics
Color	purple (dark-purple to dark purple-brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-2098-01	1 in 1 CARTON	06/14/2021
1		118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/14/2021

Labeler - Haleon US Holdings LLC (079944263)