Guaifenesin

Guaifenesin
SPL v9
SPL
SPL Set ID 312ce620-4841-7488-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2016-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg)
Inactive Ingredients
Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate Saccharin Sodium Sorbitol Citric Acid Monohydrate

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-02-09
Description

NDC 58657-509-16 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 58657-509-16 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 58657-509-16

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 2 to 4 teaspoonfuls 

    12 years and over every 4 hours 

    children 6 years to 1 to 2 teaspoonfuls 

    under 12 years every 4 hours 

    children 2 years to ½ to 1 teaspoonful 

    under 6 years every 4 hours 

    children under 2 years ask a doctor

Drug Facts (continued)

Other Information
  • store at 20°-25°C (68°-77°F)

  • packaged with tamper evident seal under cap
Inactive Ingredients

Bitter Mask, Cherry Flavor, Citric Acid, FD&C Red#40, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution

Questions Or Comments

1-877-250-3427

Manufactured For:

Method Pharmaceuticals, LLC

Fort Worth, Texas 76118 Rev. 09/16

Principal Display Panel

NDC 58657- 509- 16



Guaifenesin



Liquid USP



100 mg/ 5 mL



Expectorant



16 fl. oz. (473 mL)

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 58657-509-16

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 2 to 4 teaspoonfuls 

    12 years and over every 4 hours 

    children 6 years to 1 to 2 teaspoonfuls 

    under 12 years every 4 hours 

    children 2 years to ½ to 1 teaspoonful 

    under 6 years every 4 hours 

    children under 2 years ask a doctor

Drug Facts (continued)

Other Information (Other information)
  • store at 20°-25°C (68°-77°F)

  • packaged with tamper evident seal under cap
Inactive Ingredients (Inactive ingredients)

Bitter Mask, Cherry Flavor, Citric Acid, FD&C Red#40, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution

Questions Or Comments (Questions or Comments)

1-877-250-3427

Manufactured For:

Method Pharmaceuticals, LLC

Fort Worth, Texas 76118 Rev. 09/16

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 58657- 509- 16



Guaifenesin



Liquid USP



100 mg/ 5 mL



Expectorant



16 fl. oz. (473 mL)

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: 2026-02-15T12:04:34.340960 · Updated: 2026-03-14T23:13:16.476899