Dextromethorphan HBr 15 mg description, usages, side effects, indications, overdosage, supplying and lots more!

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Dextromethorphan HBr 15 mg

Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

Dextromethorphan HBr Capsules 15 mg, liquid filled


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Dextromethorphan HBr, USP 15 mg

Purpose

Cough suppressant

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

Dextromethorphan HBr 15 mg 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 15 mg

Dextromethorphan HBr CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53345-011
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg

Inactive Ingredients

Ingredient Name Strength
FD&C RED NO. 40
FD&C BLUE NO. 1
GELATIN
GLYCERIN
polyethylene glycol 400
povidone
water
propylene glycol
sorbitol

Product Characteristics

Color Size Imprint Code Shape
red (CLEAR) 10 mm PC6 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12000 in 1 BAG
2 NDC:53345-011-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-01-30


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Be sure to consult your doctor before taking any medication!
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