ROBITUSSIN MAXIMUM STRENGTH NIGHTTIME COUGH DM- dextromethorphan hydrobromide, 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 20 ml)

Dextromethorphan HBr, USP 30 mg

Doxylamine Succinate, USP 12.5 mg

Purposes

Cough suppressant

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
this adult product is not intended for use in children under 12 years of age
agedose

adults and children 12 years and over

20 ml every 6 hours

children under 12 years

do not use

Other information

each 20 ml contains: sodium 14 mg
store at 20-25°C (68-77°F)

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, triacetin, xanthan gum

Questions or comments?

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

Made in Canada

For most recent product information, visit www.robitussin.com

Distributed by:
Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL

ADULT

Robitussin®

MAXIMUM STRENGTH

Nighttime
Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
DOXYLAMINE SUCCINATE (Antihistamine)

Controls Cough
Relieves Runny Nose
& Sneezing

FAST, EFFECTIVE
cough relief

DM
NIGHTTIME
MAX

For Ages 12 & Over
4 FL OZ (118 ml)

Robitussin MS NT Cough 4 oz
ROBITUSSIN MAXIMUM STRENGTH NIGHTTIME COUGH DM 
dextromethorphan hydrobromide, doxylamine succinate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8718
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 20 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TRIACETIN (UNII: XHX3C3X673)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8718-131 in 1 CARTON06/01/2016
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2NDC:0031-8718-181 in 1 CARTON06/01/2016
2237 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
3NDC:0031-8718-241 in 1 CARTON06/01/2016
3355 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/2016
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
PF Consumer Healthcare Canada ULC203812479ANALYSIS(0031-8718) , LABEL(0031-8718) , MANUFACTURE(0031-8718) , PACK(0031-8718)

Revised: 1/2023
Document Id: f73b00e8-032c-4bc3-bffe-9d35cb0f2395
Set id: 44feee2f-25bc-48d4-8e13-db1d9daaaa90
Version: 5
Effective Time: 20230120
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC