Mucus Relief Guaifenesin 400 Mg Caplets

Mucus Relief Guaifenesin 400 Mg Caplets
SPL v1
SPL
SPL Set ID 15f22ab1-4b84-b999-e063-6394a90a59be
Route
ORAL
Published
Effective Date 2017-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg)
Inactive Ingredients
Silicon Dioxide Magnesium Stearate Cellulose, Microcrystalline Stearic Acid Povidone Maltodextrin Croscarmellose Sodium

Identifiers & Packaging

Pill Appearance
Imprint: S400 Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-04-13

Description

Guaifenesin 400 mg

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin 400 mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus
Section 53414-9

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

Warnings

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)
Directions:
  • adults and children 12 years of age and over: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:do not use
Other Information
  • each tablet contains: sodium 1.24 mg VERY LOW SODIUM
  • store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
  • keep in a dry place and do not expose to heat
  • read all product information before using
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients

colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, stearic acid, sodium starch glycolate

Questions Or Comments

www.getnewvue.com

Principal Display Panel

300 ct

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.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet)

Guaifenesin 400 mg


Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus
Section 53414-9 (53414-9)

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

Purpose

Expectorant

Warnings

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)
Directions:
  • adults and children 12 years of age and over: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:do not use
Other Information (Other information)
  • each tablet contains: sodium 1.24 mg VERY LOW SODIUM
  • store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
  • keep in a dry place and do not expose to heat
  • read all product information before using
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, stearic acid, sodium starch glycolate

Questions Or Comments (Questions or Comments)

www.getnewvue.com

Principal Display Panel

300 ct

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • do not use for more than 7 days
Stop Use and Ask A Doctor If (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.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Guaifenesin 400 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)