ROBITUSSIN LONG-ACTING COUGH SOFT CHEWS- dextromethorphan hydrobromide tablet, chewable

ROBITUSSIN LONG-ACTING COUGH Soft CHEWS by

Drug Labeling and Warnings

ROBITUSSIN LONG-ACTING COUGH Soft CHEWS by is a Otc medication manufactured, distributed, or labeled by Haleon US Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each chewable tablet)

Dextromethorphan equivalent to dextromethorphan HBr 15 mg

PURPOSE

Purpose

Cough suppressant

INDICATIONS & USAGE

Use

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

WARNINGS

Warnings

Do not useif 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

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

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.

DOSAGE & ADMINISTRATION

Directions

• do not take more than 4 doses (8 chewable tablets) in any 24-hour period
• this adult product is not intended for use in children under 12 years of age

age		dose
adults and children 12 years and over		take 2 chewable tablets every 6 to 8 hours, as needed
children under 12 years		do not use

STORAGE AND HANDLING

Other information

• each chewable tablet contains:potassium 10 mg, sodium 6 mg
• store at a controlled room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, FD&C red no. 40, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk

QUESTIONS

Questions or comments?

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

Additional Information

Do Not Use if seal under bottle cap imprinted with

“SEALED for YOUR PROTECTION” is broken or missing.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineabuse.org

Distributed by: Haleon, Warren, NJ 07059

Trademarks are owned by or licensed to the Haleon group of companies.

Pat. Info www.productpats.com

©2023 Haleon group of companies or its licensor.

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

PRINCIPAL DISPLAY PANEL

NEW! ADULT HALEON

Robitussin

Long-Acting Cough

Soft CHEWS

DEXTROMETHORPHAN HBr 15 mg
(Cough Suppressant)

FAST relief ANYWHERE

UP TO 8HRCOUGH RELIEF

Chew tablets completely before swallowing

Berry flavor

10 CHEWABLE TABLETS

208802 Front Label

INGREDIENTS AND APPEARANCE

ROBITUSSIN LONG-ACTING COUGH SOFT CHEWS 
dextromethorphan hydrobromide tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-9310
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CORN SYRUP (UNII: 9G5L16BK6N)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MANNITOL (UNII: 3OWL53L36A)
STARCH, CORN (UNII: O8232NY3SJ)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SORBITOL (UNII: 506T60A25R)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
COW MILK (UNII: 917J3173FT)

Product Characteristics
Color	pink (darker pink speckles)	Score	no score
Shape	ROUND	Size	21mm
Flavor	BERRY	Imprint Code	R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-9310-10	10 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2024
2	NDC: 0031-9310-20	20 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/19/2024

Labeler - Haleon US Holdings LLC (079944263)