LONG ACTING COUGH SOFTGELS- dextromethorphan hbr 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 CHAIN DRUG MARKETING ASSOCIATION INC, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each liquid-filled capsule)

Dextromethorphan HBr, USP 15 mg

Purpose

Cough suppressant

Uses

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

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.

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 (1-800-222-1222) right away.

Directions

• do not take more than 8 capsules 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 over: take 2 capsules every 6 to 8 hours, as needed
  
• children under 12 years: do not use
  

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°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, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

Questions or comments?

1-800-426-9391

Principal display panel

QUALITY
CHOICE®

NDC: 63868-447-20

*Compare to the
Active Ingredient in
Robitussin® CoughGels®

Long Acting Cough Softgels
Dextromethorphan HBr, USP 15 mg

Cough Suppressant
Up to 8 Hours | For Ages 12 & Over
Non-Drowsy | Non-Narcotic Formula

20 Softgels

actual size

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

50844 ORG031966109

Product of China
Packaged and Quality Assured in the USA

Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

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

Quality Choice 44-661

INGREDIENTS AND APPEARANCE

LONG ACTING COUGH SOFTGELS 
dextromethorphan hbr capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-447
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 (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	RED (clear)	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	661
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-447-20	1 in 1 CARTON	08/07/2019
1		20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/07/2019

Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(63868-447)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(63868-447)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(63868-447)