ROBITUSSIN HONEY MAXIMUM STRENGTH NIGHTTIME COUGH DM- dextromethorphan hbr, doxylamine succinate solution 
Haleon US Holdings LLC

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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:
    • 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 aretaking 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 ifcough 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 21 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 USA

PRINCIPAL DISPLAY PANEL

ADULT

NEW!

Robitussin ®

Honey

Nighttime
Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
DOXYLAMINE SUCCINATE (Antihistamine)

MAXIMUM STRENGTH

  1. Controls Cough
  2. Relieves runny nose and sneezing

Taste the
Real Honey

DM
NIGHTTIME
MAX

For Ages 12+
4 FL OZ (118 ml)

Robitussin Honey MS NT Cough 4 fl ozs (118 ml)
ROBITUSSIN HONEY MAXIMUM STRENGTH NIGHTTIME COUGH DM 
dextromethorphan hbr, doxylamine succinate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8758
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)  
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:0031-8758-121 in 1 CARTON06/25/2018
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2NDC:0031-8758-181 in 1 CARTON06/25/2018
2237 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 DrugM01206/25/2018
Labeler - Haleon US Holdings LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
Pf Soins De Sante Sri203812479analysis(0031-8758) , label(0031-8758) , manufacture(0031-8758) , pack(0031-8758)

Revised: 3/2024
Document Id: 1402af71-cf94-1ceb-e063-6294a90a3668
Set id: 0b41da13-18a1-4987-ae43-1319bfa27484
Version: 8
Effective Time: 20240319
 
Haleon US Holdings LLC