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← See all Robitussin Maximum Strength Nighttime Cough DM brands

Robitussin Maximum Strength Nighttime Cough DM

Dosage form: solution
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 30mg in 20mL, DOXYLAMINE SUCCINATE 12.5mg in 20mL
Labeler: Richmond Division of Wyeth
NDC Code: 0031-8718

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.

Robitussin® Maximum Strength Nighttime Cough DM

Drug Facts

Active ingredients (in each 20 ml)Purposes
Dextromethorphan HBr, USP 30 mgCough suppressant
Doxylamine Succinate, USP 12.5 mgAntihistamine

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

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 over20 ml every 6 hours
children under 12 yearsdo 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 - 118 ml Bottle Label

ADULT

Robitussin®

MAXIMUM STRENGTH

Nighttime
Cough DM

DM
NIGHTTIME
MAX

DEXTROMETHORPHAN HBr (Cough Suppressant)
DOXYLAMINE SUCCINATE (Antihistamine)

4 FL OZ (118 ml)

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

See
New
Dosing

ADULT

Robitussin®

MAXIMUM STRENGTH

Nighttime
Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
DOXYLAMINE SUCCINATE (Antihistamine)

Controls Cough
Relieves Runny Nose
& Sneezing

DM
NIGHTTIME
MAX

BETTER
TASTING!

Same Effective
Nighttime Relief*

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

ROBITUSSIN MAXIMUM STRENGTH NIGHTTIME COUGH DM 
dextromethorphan hydrobromide, doxylamine succinate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8718
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 20 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE12.5 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
DEXTROSE, UNSPECIFIED FORM 
MENTHOL, UNSPECIFIED FORM 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE, UNSPECIFIED FORM 
SUCRALOSE 
TRIACETIN 
XANTHAN GUM 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0031-8718-131 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:0031-8718-181 BOTTLE in 1 CARTON
2237 mL in 1 BOTTLE
3NDC:0031-8718-241 BOTTLE in 1 CARTON
3355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/01/2016
Labeler - Richmond Division of Wyeth (829390835)
Establishment
NameAddressID/FEIOperations
Pfizer Canada Inc.246770197ANALYSIS(0031-8718), LABEL(0031-8718), MANUFACTURE(0031-8718), PACK(0031-8718)

 
Richmond Division of Wyeth

← See all Robitussin Maximum Strength Nighttime Cough DM brands

Medically reviewed on Sep 17, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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