DEXTROMETHORPHAN HBR 15 MG- dextromethorphan hbr capsule, liquid filled

Dextromethorphan HBr 15 mg by

Drug Labeling and Warnings

Dextromethorphan HBr 15 mg by is a Otc medication manufactured, distributed, or labeled by Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Dextromethorphan HBr, USP 15 mg

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 the user has

• 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 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.

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 of age and over:

  take 2 capsules every 6 to 8 hours, as needed

• children under 12 years of age:

  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

FD&C blue #1, FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Wuhan, Hubei
430206, China

Questions or comments?

Call toll free 1-855-215-8180

PRINCIPAL DISPLAY PANEL - Shipping Label

Dextromethorphan HBr Capsules, 15 mg

Quantity : 12000 Capsules
NDC No. : 53345-028-01

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

INGREDIENTS AND APPEARANCE

DEXTROMETHORPHAN HBR 15 MG 
dextromethorphan hbr capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53345-028
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 RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red (CLEAR)	Score	no score
Shape	CAPSULE (OVAL)	Size	10mm
Flavor		Imprint Code	661
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53345-028-01	1 in 1 BOX	12/10/2014
1		12000 in 1 BAG; 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	12/10/2014

Labeler - Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. (421293287)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.		421293287	MANUFACTURE(53345-028) , ANALYSIS(53345-028)