ROBITUSSIN MEDI-SOOTHERS- dextromethorphan hydrobromide, menthol lozenge

Robitussin Medi-Soothers by

Drug Labeling and Warnings

Robitussin Medi-Soothers by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each lozenge)

Dextromethorphan HBr 5 mg

Menthol 5 mg

Purposes

Cough suppressant

Oral anesthetic

Uses

temporarily relieves

• cough due to minor throat and bronchial irritation as may occur with the common 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, 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

• adults and children 12 years of age and older: take 2 lozenges (one immediately after the other) every 4 hours as needed. Allow each lozenge to dissolve slowly in the mouth.
• do not take more than 12 lozenges in any 24-hour period, or as directed by a doctor
• children under 12 years of age: do not use

Other information

• store at 20°-25°C (68°-77°F)

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

• Relieves Cough for up to 4 HOURS
• Relieves Sore Throat Pain

Elderberry Flavor

Actual Size

For Ages 12+

16 MEDICATED LOZENGES

202559 Front Carton

INGREDIENTS AND APPEARANCE

ROBITUSSIN MEDI-SOOTHERS 
dextromethorphan hydrobromide, menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-9307
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	purple	Score	no score
Shape	OVAL	Size	25mm
Flavor	BERRY (Elderberry)	Imprint Code	R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-9307-01	16 in 1 BLISTER PACK; Type 0: Not a Combination Product	06/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/01/2023

Labeler - Haleon US Holdings LLC (079944263)