Guaifenesin by KESIN PHARMA CORPORATION / Kesin Pharma GUAIFENESIN liquid

Guaifenesin by

Drug Labeling and Warnings

Guaifenesin by is a Otc medication manufactured, distributed, or labeled by KESIN PHARMA CORPORATION, Kesin Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Guaifenesin, USP 100 mg

Purpose

Expectorant

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

• if you ever had an allergic reaction to any of the ingredients in this product

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

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.

Keep out of reach of children.

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

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

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

SPL UNCLASSIFIED SECTION

*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

PRINCIPAL DISPLAY PANEL

NDC: 81033-102-16

Guaifenesin Oral Solution, USP

100 mg/5 mL

Expectorant

Grape Flavor

16 fl oz (473 mL)

INGREDIENTS AND APPEARANCE

GUAIFENESIN 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81033-102
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)
METHYLPARABEN (UNII: A2I8C7HI9T)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
SORBITOL (UNII: 506T60A25R)
CITRIC ACID (UNII: 2968PHW8QP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81033-102-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/01/2025

Labeler - KESIN PHARMA CORPORATION (117447816)

Establishment
Name	Address	ID/FEI	Business Operations
Kesin Pharma		117447816	pack(81033-102) , label(81033-102)