CHILDRENS ROBITUSSIN HONEY NIGHTTIME COUGH DM- dextromethorphan hbr, doxylamine succinate solution

Childrens Robitussin Honey Nighttime Cough DM by

Drug Labeling and Warnings

Childrens Robitussin Honey Nighttime Cough 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 15 mg	Cough suppressant
Doxylamine Succinate, USP 6.25 mg	Antihistamine

INDICATIONS & USAGE

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

• each 10 ml contains: sodium 10 mg
• store at 20–25°C (68–77°F)

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 6+

Nighttime
Cough
DM

Dextromethorphan HBr (Cough Suppressant)
Doxylamine Succinate (Antihistamine)

ALCOHOL FREE
4 FL OZ (118 ml)

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

Children's
Robitussin®
Honey
For Ages 6+

Nighttime
Cough
DM

DEXTROMETHORPHAN HBR
(COUGH SUPPRESSANT)
DOXYLAMINE SUCCINATE (ANTIHISTAMINE)

ALCOHOL
FREE

LONG-ACTING

•   Relieves:
• ✓ Cough up to 8 hours
• ✓ Runny nose

Taste the
Real Honey

TRUE
SOURCE
CERTIFIED
HONEY ✓

4 FL OZ (118 ml)

INGREDIENTS AND APPEARANCE

CHILDRENS ROBITUSSIN HONEY NIGHTTIME COUGH DM 
dextromethorphan hbr, doxylamine succinate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-8762
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 10 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 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: 0031-8762-12	1 in 1 CARTON	05/27/2019
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	05/27/2019

Labeler - Wyeth Consumer Healthcare LLC (828831730)

Establishment
Name	Address	ID/FEI	Business Operations
PF Consumer Healthcare Canada ULC		203812479	ANALYSIS(0031-8762) , LABEL(0031-8762) , MANUFACTURE(0031-8762) , PACK(0031-8762)