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

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GUAIFENESIN

AvKARE, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

(in each immediate-release tablet)
Guaifenesin 400 mg

Purpose

Expectorant

GUAIFENESIN Uses

  • Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus.

Ask a doctor before use if you have

  • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

  • Cough accompanied by excessive phlegm (mucus)

When using this product

  • do not exceed recommended dosage
  • do not use for more than 7 days

Stop use and ask a doctor if

  • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding

ask a healthcare 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

  • adults and children 12 years of age and older, take 1 tablet every 4 hours with a full glass of water while symptoms persist.Do not exceed 6 doses in 24 hours.
  • children under 12 years of age do not use.

GUAIFENESIN Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • keep in a dry place and do not expose to excessive heat

Inactive ingredients

Colloidal Silicon Dioxide, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid

Principal display panel

AvKARE
NDC
42291-312-30

Immediate-release
GUAIFENESIN

EXPECTORANT
• Relieves Chest Congestion
• Thins and Loosens Mucus

400 mg

30 Tablets

TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING

Manufactured for: AvKARE, Inc. Pulaski, TN 38478

Lot:
Exp Date:

AV 05/12

GUAIFENESIN

GUAIFENESIN TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42291-312(NDC:49483-272)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Guaifenesin GUAIFENESIN 400 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
maltodextrin
cellulose, microcrystalline
povidone
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
WHITE 12 mm TCL272 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42291-312-30 30 in 1 BOTTLE
2 NDC:42291-312-60 60 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-05-16


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Be sure to consult your doctor before taking any medication!
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