ADULT LONG LASTING-COUGH RELIEF- dextromethorphan hbr,usp capsule

Adult Long Lasting-Cough Relief by

Drug Labeling and Warnings

Adult Long Lasting-Cough Relief by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium LLC, Marksans Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Dextromethorphan HBr, USP 15 mg 

PURPOSE

Cough Suppressant 

USE(S)

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

WARNINGS

DO NOT USEYou 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

• 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 DOCTOR 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.

PREGNANCY/BREASTFEEDING

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

• do not take more than 8 liquidgels in any 24-hour period
• adults and children 12 years and over: take 2 liquidgels every 6 to 8 hours, as needed 
• children under 12 years: ask a doctor

STORAGE

• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 
• store at 20º-25ºC (68º-77ºF)
• avoid excessive heat above 40ºC (104ºF)
• protect from light
• use by expiration date on package

INACTIVE INGREDIENTS

Gelatin, Sorbitol, Sorbitan, FD&C Blue No.1, Water, Polyethylene Glycol 400, Povidone K-30, Glycerine, FD&C Red No. 40, Propylene Glycol.

PRINCIPAL DISPLAY PANEL

CARTON LABEL PDP

NDC # 68016-026-20

Adult Long-Lasting Cough Relief
DEXTROMETHORPHAN HBr, USP 15mg
COUGH SUPPRESSANT

Relieves cough for upto 8 hours
Non-drowsy
Non-Narcotic formula

20 softgels





BOTTLE LABEL PDP

NDC # 68016-026-20

Adult Long-Lasting Cough Relief
DEXTROMETHORPHAN HBr, USP 15mg
COUGH SUPPRESSANT

Relieves cough for about 8 hours
Non-Drowsy
Non-Narcotic Formula

20 Softgels

INGREDIENTS AND APPEARANCE

ADULT LONG LASTING-COUGH RELIEF 
dextromethorphan hbr,usp capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-026
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
GELATIN (UNII: 2G86QN327L)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	RED	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	26
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-026-20	1 in 1 CARTON
1		20 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/22/2013

Labeler - Chain Drug Consortium LLC (101668460)

Registrant - Chain Drug Consortium LLC (101668460)

Establishment
Name	Address	ID/FEI	Business Operations
Marksans Pharma Limited		925822975	MANUFACTURE(68016-026)