SPL v1
SPL
SPL Set ID cb7cd1df-8cfb-4a9c-9567-809a2343622e
Route
ORAL
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (1200 mg)
Inactive Ingredients
Hypromellose, Unspecified Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Sodium Starch Glycolate Type A Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: G;1200 Shape: oval Color: white Size: 21 mm Score: 1
Marketing Status
ANDA Active Since 2020-12-18

Description

Guaifenesin  1200 mg

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin  1200 mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings

Do not use

  • for children under 12 years of age
Directions
  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years of age and over:1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. 
  • children under 12 years of age:do not use
Questions?

call toll-free 1-800-630-8895

Other Information
  • store between 20-25°C (68-77°F).
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.
Active Ingredients 

Guaifenesin  1200 mg

Inactive Ingredients

carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Principal Display Panel

Stop Use and Ask A Doctor If
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

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 too much phlegm (mucus)

Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose

Expectorant

Warnings

Do not use

  • for children under 12 years of age
Directions
  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years of age and over:1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. 
  • children under 12 years of age:do not use
Questions?

call toll-free 1-800-630-8895

Other Information (Other information)
  • store between 20-25°C (68-77°F).
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.
Active Ingredients  (Active ingredients )

Guaifenesin  1200 mg

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
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  (1-800-222-1222) right away.

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

ask a health professional before use.

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 too much phlegm (mucus)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)