SPL v1
SPL
SPL Set ID 1006906e-d6d7-4f49-92bf-3cb2d2cdbb16
Route
ORAL
Published
Effective Date 2025-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg)
Inactive Ingredients
Citric Acid Fd&c Red No. 40 Glycerin Menthol Methylparaben Potassium Sorbate Propylene Glycol Propylparaben Water Sodium Citrate Sucralose Strawberry

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-16

Description

Guaifenesin,USP 100 mg (in each 5ml tsp)

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin,USP 100 mg (in each 5ml tsp)

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Section 50565-1

Warnings

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Stop use and ask a doctor if■ cough persists for more than a week, tends to recur, or is accompanied by a fever, rash or persistent headache, consult a doctor. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions
  • Do not take more than 6 doses in any 24 hours period
 age  dose

 Adults and Children 12 years of age and over:

Children under 12 years of age:

 Take 2-4 teaspoonful (5mL) every 4 hours

Consult a physician

Product Label

Other Information
  • store at room temperature ■ 15°-30°C (59°-86°F)
  • TAMPER-EVIDENT: Do not use if seal under cap is torn, broken or missing.
Active Ingredient 

Guaifenesin,USP 100 mg (in each 5ml tsp)

Inactive Ingredients

Citric acid, FD&C yellow #5, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, strawberry-banana flavor, sucralose.

Questions Or Comments? 1 888 462 4166


Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Section 50565-1 (50565-1)

Purpose

Expectorant

Warnings

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Stop use and ask a doctor if■ cough persists for more than a week, tends to recur, or is accompanied by a fever, rash or persistent headache, consult a doctor. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions
  • Do not take more than 6 doses in any 24 hours period
 age  dose

 Adults and Children 12 years of age and over:

Children under 12 years of age:

 Take 2-4 teaspoonful (5mL) every 4 hours

Consult a physician

Product Label (Product label)

Other Information
  • store at room temperature ■ 15°-30°C (59°-86°F)
  • TAMPER-EVIDENT: Do not use if seal under cap is torn, broken or missing.
Active Ingredient 

Guaifenesin,USP 100 mg (in each 5ml tsp)

Inactive Ingredients

Citric acid, FD&C yellow #5, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, strawberry-banana flavor, sucralose.

Questions Or Comments? 1 888 462 4166 (Questions or Comments? 1-888-462-4166)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)