ROBITUSSIN MEDI-SOOTHERS COUGH DM- dextromethorphan hydrobromide and menthol lozenge 
Richmond Division of Wyeth

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

PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton
ROBITUSSIN MEDI-SOOTHERS COUGH DM 
dextromethorphan hydrobromide and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8649
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
CARAMEL (UNII: T9D99G2B1R)  
CORN SYRUP (UNII: 9G5L16BK6N)  
ALCOHOL (UNII: 3K9958V90M)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize25mm
FlavorHONEY, LEMONImprint Code R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8649-044 in 1 CARTON09/01/201406/30/2017
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0031-8649-1616 in 1 CARTON09/01/201406/30/2017
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0031-8649-054 in 1 CARTON09/01/201406/30/2017
31 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/01/201406/30/2017
Labeler - Richmond Division of Wyeth (829390835)

Revised: 11/2018
Document Id: 2ee53258-3ef2-4b3c-8ecb-cf897fb611e6
Set id: 40a9b571-64cc-473b-9d79-8be6634b11cb
Version: 3
Effective Time: 20181112
 
Richmond Division of Wyeth