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Robitussin Medi-Soothers Cough DM

Medically reviewed on Nov 24, 2017

Dosage form: lozenge
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 5mg, MENTHOL, UNSPECIFIED FORM 5mg
Labeler: Richmond Division of Wyeth
NDC Code: 0031-8649

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® Medi-Soothers™ Cough DM

Drug Facts

Active ingredients (in each lozenge)Purposes
Dextromethorphan HBr 5 mgCough suppressant
Menthol 5 mgOral anesthetic

Uses

Temporarily relieves:

  • cough due to minor throat and bronchial irritation as may occur with a cold
  • occasional minor irritation, pain, sore mouth, and sore throat

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use 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
  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Stop use and ask a doctor or dentist if
  • cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore mouth symptoms do not improve in 7 days

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

  • do not take more than 12 lozenges in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
  • allow lozenges (one immediately after the other) to dissolve slowly in the mouth
agedose
adults and children 12 years of age and over2 lozenges every 4 hours
children under 12 yearsdo not use

Other information

  • store at 20-25°C (68-77°F). Store in a dry place.

Inactive ingredients

acacia, ascorbyl palmitate, beta-carotene, caramel, corn syrup, dehydrated alcohol, dextrin, glycerin, high fructose corn syrup, lecithin, natural & artificial flavors, propylene glycol, purified water, sucralose, sucrose, sunflower oil, vitamin E

Questions or comments?

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

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

Distributed by:
Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton

ADULT

NEW!

Robitussin®

Medi-Soothers

Cough

DEXTROMETHORPHAN HBr
(Cough Suppressant)
MENTHOL (Oral Anesthetic)

DM

Relieves:

Cough
Sore Throat

REAL MEDICINE
+ SOOTHING
LIQUID CENTER!

HONEY LEMON

For Ages 12 & Over

16 MEDICATED LOZENGES

ROBITUSSIN MEDI-SOOTHERS COUGH DM 
dextromethorphan hydrobromide and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8649
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
ASCORBYL PALMITATE 
.BETA.-CAROTENE 
CARAMEL 
CORN SYRUP 
ALCOHOL 
ICODEXTRIN 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
EGG PHOSPHOLIPIDS 
PROPYLENE GLYCOL 
WATER 
SUCRALOSE 
SUCROSE 
SUNFLOWER OIL 
.ALPHA.-TOCOPHEROL 
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize25mm
FlavorHONEY, LEMONImprint CodeR
Contains    
Packaging
#Item CodePackage Description
1NDC:0031-8649-044 BLISTER PACK in 1 CARTON
11 LOZENGE in 1 BLISTER PACK
2NDC:0031-8649-1616 BLISTER PACK in 1 CARTON
21 LOZENGE in 1 BLISTER PACK
3NDC:0031-8649-054 BLISTER PACK in 1 CARTON
31 LOZENGE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/01/2014
Labeler - Richmond Division of Wyeth (829390835)

 
Richmond Division of Wyeth

Further information

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

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