LONG ACTING COUGH SOFTGELS- dextromethorphan hydrobromide capsule, liquid filled

Long Acting Cough Softgels by

Drug Labeling and Warnings

Long Acting Cough Softgels by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each softgel)

Dextromethorphan HBr, USP 15mg

Purpose

Cough Suppressant

Use

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

Warnings

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 as occurs with smoking, asthma, or emphysema

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These can be signs of a serious condition

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

• do not take more than 8 softgels in any 24-hour period
• this adult product is not intended for use in children under 12 years of age

• adults and children 12 years and older: take 2 softgels every 6 to 8 hours, as needed
• children under 12 years: do not use

Other information

• store at 20°-25°C (68°-77°F)
• avoid excessive heat above 40°C (104°F)
• protect from light

Inactive ingredients

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-888-577-8033 Monday-Friday

8am-4pm EST

SPL UNCLASSIFIED SECTION

CVS Health®

Compare to the active ingredient in Robitussin® CoughGels®**

Non-Drowsy

Controls cough

8 HOUR

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE

**This product is not manufactured or distributed by Pfizer Consumer Healthcare LLC, owner of the registered trademark Robitussin® CoughGels®.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2021 CVS/pharmacy
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Product of UAE
V-38084

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Packaging

INGREDIENTS AND APPEARANCE

LONG ACTING COUGH SOFTGELS 
dextromethorphan hydrobromide capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-778
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	778
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-778-23	1 in 1 CARTON	07/28/2021
1		20 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/28/2021

Labeler - CVS PHARMACY, INC (062312574)