Guaifenesin Oral Solution, Usp

Guaifenesin Oral Solution, Usp
SPL v1
SPL
SPL Set ID 31b8ad0a-3637-03db-e063-6394a90acdc3
Route
ORAL
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg)
Inactive Ingredients
Potassium Citrate Anhydrous Methylparaben Ammonium Glycyrrhizate Sorbitol Citric Acid Sucralose Propylparaben Water Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-01
Description

Active ingredient (in each 5 mL teaspoonful) Guaifenesin, USP 100 mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Active ingredient (in each 5 mL teaspoonful) Guaifenesin, USP 100 mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 42229-5

*This product is not manufactured or distributed by the owner of registered trademark of Robitussin ®.

Distributed by:

Kesin Pharma

Oldsmar, FL 34677

Revision 03/2025

Section 51945-4

NDC 81033-102-16

Guaifenesin Oral Solution, USP

100 mg/5 mL

Expectorant

Grape Flavor

16 fl oz (473 mL)

Warnings

Directions
  • take every 4 hours, as needed, or directed by a doctor
  • do not take more than 6 doses in 24 hours
  • do not exceed recommended dose

Age Dose
adults and children 12 years and over 2 to 4 tespoonfuls every 4 hours
children 6 years to under 12 years 1 to 2 teaspoonfuls every 4 hours
children 2 years to under 6 years 1/2 to 1 teaspoonful every 4 hours
under 2 years ask a doctor

Do Not Use
  • if you ever had an allergic reaction to any of the ingredients in this product
Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Guaifenesin, USP 100 mg

Other Information
  • store at 20ºC to 25ºC (68ºF to 77ºF). Protect from light.
  • do not refrigerate
  • Do not use this product of printed inner seal is broken or missing
Inactive Ingredients

citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

Questions Or Comments?

1-833-537-4679

Stop Use and Ask A Doctor If

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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, emphysema

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
Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 42229-5 (42229-5)

*This product is not manufactured or distributed by the owner of registered trademark of Robitussin ®.

Distributed by:

Kesin Pharma

Oldsmar, FL 34677

Revision 03/2025

Section 51945-4 (51945-4)

NDC 81033-102-16

Guaifenesin Oral Solution, USP

100 mg/5 mL

Expectorant

Grape Flavor

16 fl oz (473 mL)

Purpose

Expectorant

Warnings

Directions
  • take every 4 hours, as needed, or directed by a doctor
  • do not take more than 6 doses in 24 hours
  • do not exceed recommended dose

Age Dose
adults and children 12 years and over 2 to 4 tespoonfuls every 4 hours
children 6 years to under 12 years 1 to 2 teaspoonfuls every 4 hours
children 2 years to under 6 years 1/2 to 1 teaspoonful every 4 hours
under 2 years ask a doctor

Do Not Use (Do not use)
  • if you ever had an allergic reaction to any of the ingredients in this product
Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Guaifenesin, USP 100 mg

Other Information (Other information)
  • store at 20ºC to 25ºC (68ºF to 77ºF). Protect from light.
  • do not refrigerate
  • Do not use this product of printed inner seal is broken or missing
Inactive Ingredients (Inactive ingredients)

citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

Questions Or Comments? (Questions or comments?)

1-833-537-4679

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 persistant 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.

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, emphysema

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:51.263367 · Updated: 2026-03-14T23:08:12.555949