Guaifenesin

Guaifenesin
SPL v3
SPL
SPL Set ID 1539c3d4-d982-7d4e-e063-6394a90ad7d6
Route
ORAL
Published
Effective Date 2024-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg)
Inactive Ingredients
Menthol Caramel Dextrose Anhydrous Citric Acid Fd&c Red No. 40 Glycerin Water Sodium Benzoate Saccharin Sodium High Fructose Corn Syrup

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-01
Description

NDC 58657-508-16 Guaifenesin Liquid USP 100 mg/5 Ml Expectorant Sugar Free • Alcohol Free Cherry Flavor Loosens and Relieves Chest Congestion 16 fl. oz. (473 mL) Drug Facts

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

NDC 58657-508-16 Guaifenesin Liquid USP 100 mg/5 Ml Expectorant Sugar Free • Alcohol Free Cherry Flavor Loosens and Relieves Chest Congestion 16 fl. oz. (473 mL) Drug Facts

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
Section 42229-5

NDC 58657-508-16

Guaifenesin

Liquid USP

100 mg/5 Ml

Expectorant

Sugar Free • Alcohol Free

Cherry Flavor

Loosens and Relieves Chest Congestion

16 fl. oz. (473 mL)

Drug Facts

Directions
  • do not take more than 6 doses in any 24-hour period
    age dose
    adults and children 12 years and over 2 to 4 teaspoonfuls every 4 hours
    children 6 years to under 12 years 1 to 2 teaspoonfuls every 4 hours
    children 2 to under 6 yars 1/2 to 1 teaspoonful every 4 hours
    children under 2 years ask a doctor

Other Information
  • store at 20°-25°C (68°-77°F)
  • packaged with tamper evident seal under cap
  • each 5 mL contains: sodium 3 mg
Inactive Ingredients

Caramel, citric acid anhydrous, dextrose, FD&C red #40, flavor, gylcerin, high fructose corn syrup, menthol, purified water, saccharin, sodium, sodium benzoate

Questions Or Comments

1-877-250-3427

Manufactured For:

Method Pharmaceuticals, LLC

Southlake, TX 79092

LR-205

Rev-2024

Principal Display Panel

NDC 58657- 508- 16



Guaifenesin



Liquid USP



100 mg/ 5 mL



Expectorant



16 fl. oz. (473 mL)

When Using This Product
  • Do not use more than directed
Stop Use and Ask A Doctor If
  • cough lasts more than 7 days, comes back, 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 overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each 5 Ml)

Guaifenesin 100 mg

Ask A Doctor Before Use If You Have
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
Section 42229-5 (42229-5)

NDC 58657-508-16

Guaifenesin

Liquid USP

100 mg/5 Ml

Expectorant

Sugar Free • Alcohol Free

Cherry Flavor

Loosens and Relieves Chest Congestion

16 fl. oz. (473 mL)

Drug Facts

Purpose

Expectorant

Directions
  • do not take more than 6 doses in any 24-hour period
    age dose
    adults and children 12 years and over 2 to 4 teaspoonfuls every 4 hours
    children 6 years to under 12 years 1 to 2 teaspoonfuls every 4 hours
    children 2 to under 6 yars 1/2 to 1 teaspoonful every 4 hours
    children under 2 years ask a doctor

Other Information (Other information)
  • store at 20°-25°C (68°-77°F)
  • packaged with tamper evident seal under cap
  • each 5 mL contains: sodium 3 mg
Inactive Ingredients (Inactive ingredients)

Caramel, citric acid anhydrous, dextrose, FD&C red #40, flavor, gylcerin, high fructose corn syrup, menthol, purified water, saccharin, sodium, sodium benzoate

Questions Or Comments (Questions or Comments)

1-877-250-3427

Manufactured For:

Method Pharmaceuticals, LLC

Southlake, TX 79092

LR-205

Rev-2024

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 58657- 508- 16



Guaifenesin



Liquid USP



100 mg/ 5 mL



Expectorant



16 fl. oz. (473 mL)

When Using This Product (When using this product)
  • Do not use more than directed
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough lasts more than 7 days, comes back, 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 overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Guaifenesin 100 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:03.875576 · Updated: 2026-03-14T23:13:16.476899