Robafen Cough description, usages, side effects, indications, overdosage, supplying and lots more!

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Robafen Cough

Major Pharmaceuticals

Major 44-442


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each liquidgel)

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

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

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or presistent 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 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

Robafen Cough Other information

  •  store at 20º-25ºC (68º-77ºF)
  • avoid excessive heat above 40ºC (104ºF)
  • protect from light
  • use by expiration date on package

Inactive ingredients

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

Principal display panel

Major®

NDC 0904-5752-95

*Compare to the active ingredient in Robitussin® CoughGels™

Non-Drowsy Formula

ROBAFEN COUGH LIQUIDGELS

Dextromethorphan HBr, USP 15 mg

Cough Suppressant

8-Hour Cough Relief

Easy-to-Swallow Liquid-Filled Capsules

20 Liquidgels (Liquid-Filled Capsules)

Distributed by

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150

M-17

Re-order No. 100169

REV0208B44209 

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

Product of Canada

Robafen Cough
442-09

Robafen Cough

Dextromethorphan HBr CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-5752
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 BLUE NO. 1
FD&C RED NO. 40
water
sorbitol

Product Characteristics

Color Size Imprint Code Shape
RED 13 mm 33 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-5752-95 20 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2006-04-24


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Be sure to consult your doctor before taking any medication!
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