Simpex Guaifenesin

Simpex Guaifenesin
SPL v5
SPL
SPL Set ID 1594f9d6-0c48-42bf-b76b-d621f215179a
Route
ORAL
Published
Effective Date 2018-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: ; Shape: round Color: red Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-02-09
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
Directions
  • adults & children 12 years of age and older : take a 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.
Drug Facts



Other Information
  • preserve in tight containers at a temperature not exceeding 30°C.
Package Labeling:

Inactive Ingredients

colloidal anhydrous silica, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, pregelatinised starch, sodium starch glycolate type A, stearic acid

Stop Use and Ask A Doctor If
  • cough lasts more than 7 days, recurs, or is accompanied with fever, rash, or persistent headache.These could be signs of a serious condition. 
If Pregnant Or Breast Feeding,

ask a health care professional before use.

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

Ask A Doctor Before Use If You Have
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied with 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

Directions
  • adults & children 12 years of age and older : take a 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.
Drug Facts



Other Information (Other information)
  • preserve in tight containers at a temperature not exceeding 30°C.
Package Labeling:

Inactive Ingredients (Inactive ingredients)

colloidal anhydrous silica, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, pregelatinised starch, sodium starch glycolate type A, stearic acid

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough lasts more than 7 days, recurs, or is accompanied with 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 care professional before use.

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

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 with excessive phlegm (mucus)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:24.521923 · Updated: 2026-03-14T23:01:57.446196