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Dextromethorphan HBr 15 mg by Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

Dosage form: capsule, liquid filled
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 15mg
Labeler: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
NDC Code: 53345-011

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Dextromethorphan HBr Capsules 15 mg, liquid filled

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) 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. : 53345-011-01

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"

DEXTROMETHORPHAN HBR 15 MG 
dextromethorphan hbr capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-011
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
POVIDONE 
WATER 
PROPYLENE GLYCOL 
SORBITOL 
Product Characteristics
Colorred (CLEAR) Scoreno score
ShapeCAPSULE (OVAL) Size10mm
FlavorImprint CodePC6
Contains    
Packaging
#Item CodePackage Description
1NDC:53345-011-011 BAG (BAG) in 1 BOX
112000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/30/2014
Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287MANUFACTURE(53345-011), ANALYSIS(53345-011)

 
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

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Medically reviewed on Jan 30, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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