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

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Drug Facts

Active ingredients (in each 10 ml)Purposes

Dextromethorphan HBr, USP 15 mg

Cough suppressant

Doxylamine Succinate, USP 6.25 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:
o
runny nose
o
sneezing
o
itchy, watery eyes
o
itching of the nose or throat
controls the impulse to cough to help you sleep

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
agedose

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 10 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

Distributed by: Pfizer, Madison, NJ 07940 US

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:
1.
Cough up to 8 hours
2.
Runny nose

Taste the
Real Honey

TRUE
SOURCE
CERTIFIED
HONEY ✓

4 FL OZ (118 ml)

Childrens Robitussin honey NT cough DM 4 fl oz (118 ml)
CHILDRENS ROBITUSSIN HONEY NIGHTTIME COUGH DM 
dextromethorphan hbr, doxylamine succinate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8762
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 10 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (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    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8762-121 in 1 CARTON05/27/2019
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/27/2019
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
PF Consumer Healthcare Canada ULC203812479ANALYSIS(0031-8762) , LABEL(0031-8762) , MANUFACTURE(0031-8762) , PACK(0031-8762)

Revised: 1/2023
Document Id: 21d923b0-56ca-49f3-9fb1-a50a770f9539
Set id: 6afaf85b-bf0c-4c99-acf3-a34f06be20f1
Version: 7
Effective Time: 20230125
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC