ROBITUSSIN MEDI-SOOTHERS- dextromethorphan hydrobromide, menthol lozenge 
Haleon US Holdings LLC

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Drug Facts

Active ingredients (in each lozenge)

Dextromethorphan HBr 5 mg

Menthol 5 mg

Purposes

Cough suppressant

Oral anesthetic

Uses

temporarily relieves

Warnings

Sore throat warning

  • if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly

Do Not Use

  • if you are now taking 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

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor or dentist 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.
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens

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

Other information

Inactive ingredients

corn syrup, elderberry juice concentrate, glycerin, natural flavors, propylene glycol, purified water, soy lecithin, sucralose, sucrose

Questions or comments?

call weekdays from 8 am to 6 pm EST at 1-800-245-1040

Additional Information

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Keep carton for complete information.

Do not use if blister is broken or damaged.

Distributed by: Haleon, Warren, NJ 07059

Trademarks owned or licensed by Haleon.

©2023 Haleon or licensor.

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

Principal Display Panel

NEW! ADULT

Robitussin

Elderberry

MEDI-SOOTHERS

DEXTROMETHORPHAN HBr (Cough Suppressant) 5 mg

Menthol (Oral Anesthetic) 5 mg

Cough + Sore Throat

Taste the Real Elderberry

Elderberry Flavor

Actual Size

For Ages 12+

16 MEDICATED LOZENGES

202559 Front Carton

Robitussin Medi-Soothers Elderberry 16 Medicated Lozenges

ROBITUSSIN MEDI-SOOTHERS 
dextromethorphan hydrobromide, menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-9307
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, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 mg
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP (UNII: 9G5L16BK6N)  
EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorpurpleScoreno score
ShapeOVALSize25mm
FlavorBERRY (Elderberry) Imprint Code R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-9307-0116 in 1 BLISTER PACK; Type 0: Not a Combination Product06/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/01/2023
Labeler - Haleon US Holdings LLC (079944263)

Revised: 4/2024
Document Id: 1571df1a-4352-e93d-e063-6294a90a576a
Set id: 4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae5
Version: 2
Effective Time: 20240406
 
Haleon US Holdings LLC