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

Childrens Robitussin Honey Cough and Chest Congestion DM by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 10 ml)	Purposes
Dextromethorphan HBr, USP 10 mg	Cough suppressant
Guaifenesin, USP 100 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

Warnings

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

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.

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 10 ml contains: sodium 11 mg
• store at 20-25°C (68-77°F). Do not refrigerate.

INACTIVE INGREDIENT

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

Questions or comments?

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

SPL UNCLASSIFIED SECTION

Distributed by: Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

Children's
Robitussin®

Honey

For Ages 4+

Cough & Chest
Congestion

DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

NON-DROWSY

4 FL OZ (118 ml)

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

Children's

NEW!

Robitussin®

Honey

For Ages 4+

Cough & Chest
Congestion

DM

DEXTROMETHORPHAN HBr
(Cough Suppressant)
GUAIFENESIN (Expectorant)

NON-DROWSY

Relieves:
✓ Chest congestion
✓ Mucus
✓ Cough

Taste the
Real Honey

TRUE
SOURCE
CERTIFIED
HONEY✓

4 FL OZ (118 ml)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-8760
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
HONEY (UNII: Y9H1V576FH)
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		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8760-12	1 in 1 CARTON	06/25/2018
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/25/2018

Labeler - Richmond Division of Wyeth (829390835)

Establishment
Name	Address	ID/FEI	Business Operations
PF Consumer Healthcare Canada ULC		203812479	ANALYSIS(0031-8760) , LABEL(0031-8760) , MANUFACTURE(0031-8760) , PACK(0031-8760)