ROBAFEN COUGH FORMULA description, usages, side effects, indications, overdosage, supplying and lots more!

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ROBAFEN COUGH FORMULA

Major Pharmaceuticals

ROBAFEN™ COUGH FORMULA


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each teaspoonful (5 mL))

Guaifenesin USP 100 mg

Purpose

Expectorant

ROBAFEN COUGH FORMULA Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Ask a doctor before use if

  • you have a cough that lasts or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough occurs with too much phlegm (mucus)

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

do not take more than 6 doses in any 24 hour period

adults and children 12 years and over 2 - 4 teaspoons every 4 hours or as directed by a doctor
children under 12 years do not use

ROBAFEN COUGH FORMULA Other information

  • each teaspoonful (5 mL) contains: sodium 3 mg
  • store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

caramel powder, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium saccharin

Questions?

Adverse Drug Event Call: (800) 616-2471

Distributed by
MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 0904-0061-16
TAMPER-EVIDENT

Robafen
Syrup

(brand of Guaifenesin syrup USP
100 mg per 5 mL)

EXPECTORANT

Each teaspoonful (5 mL) contains:

Guaifenesin
  (Glyceryl Guaiacolate), USP    100 mg

TAMPER-EVIDENT: Do not use this product
if inner foil seal over the mouth of the
bottle is cut, torn, broken or missing.

For Dispensing Purpose Only

Distributed by
MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA

NET: 1 Pint (473 mL)

MAJOR ®
PHARMACEUTICALS

ROBAFEN COUGH FORMULA

ROBAFEN COUGH FORMULA

Guaifenesin SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-0061
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Guaifenesin GUAIFENESIN 100 mg

Inactive Ingredients

Ingredient Name Strength
propylene glycol
SODIUM BENZOATE
saccharin sodium
ANHYDROUS CITRIC ACID
GLYCERIN
MENTHOL
CORN SYRUP
water
CARAMEL
FD&C RED NO. 40

Product Characteristics

Color
BROWN (Reddish-Brown)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-0061-00 118 in 1 BOTTLE
2 NDC:0904-0061-09 237 in 1 BOTTLE
3 NDC:0904-0061-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-08-15


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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