Mucosa Guifenesin

Mucosa Guifenesin
SPL v5
SPL
SPL Set ID 9d22c208-d0ae-8b6a-e053-2995a90ab90a
Route
ORAL
Published
Effective Date 2020-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg)
Inactive Ingredients
Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Microcrystalline Cellulose Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AH370 Shape: oval Color: white Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-24
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
Warnings

Directions
 Adults and  children 12 years  of age and older:  Take one 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

Questions?

call toll-free 1-800-935-6737

Other Information
  • store at controlled room temperature 15° to 30°C (59° to 86°F)
Package Labeling:

Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, microcrystalline cellulose, silicon dioxide, stearic acid.

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 health professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Guaifenesin 400 mg

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)

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
Purpose

Expectorant

Warnings

Directions
 Adults and  children 12 years  of age and older:  Take one 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

Questions?

call toll-free 1-800-935-6737

Other Information (Other information)
  • store at controlled room temperature 15° to 30°C (59° to 86°F)
Package Labeling:

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dicalcium phosphate, microcrystalline cellulose, silicon dioxide, stearic acid.

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.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have (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)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:09.381507 · Updated: 2026-03-14T23:01:35.007581