Guaifenesin by KESIN PHARMA CORPORATION / Wittman Pharma, Inc. / Kesin Pharma GUAIFENESIN liquid

Guaifenesin by

Drug Labeling and Warnings

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

Drug Details [pdf]

Guaifenesin Solution 5mL

Expectorant
Sugar Free / Dye Free / Alcohol Free

Description

Each 5mL (1 teaspoonful) contains: Guaifenesin 100mg

Inactive Ingredients

Mixture of Guaifenesin with GRAS material additions including Citric Acid, Grape Flavor Methylparaben, Monoammonium Glycyrrhizate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Warnings

Warnings
Ask a doctor before us 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

Stop and ask a doctor if
cough lasts mor than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
you are hypersensitive to any of the ingredients

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.

Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

Directions

Follow dosage below or use as directed by a physician.
Do not take more than 6 doses in any 24-hour period

• Age: Dose
• Adults and children 12 years and over: 10 to 20mL (2 to 4 teaspoonfuls) every 4 hours
• Children 6 years to under 12 years: 5 to 10mL (1 to 2 teaspoonfuls) every 4 hours
• Children 2 to under 6 years of age: 2.5 to 5mL (1/2 to 1 teaspoonful) every 4 hours
• Children under 2 years of age: Consult a physician

How Supplied:

Guaifenesin Oral Solution is a clear, colorless solution with a grape flavor, free of visible foreign matter supplied in the following oral dosage forms:

NDC: 81033-102-05: 5mL unit dose cup
NDC: 81033-102-51: Case containing 100 unit dose cups of 5 mL packaged in 2 cartons of 50 unit dose cups each
NDC: 81033-102-10: 10mL unit dose cup
NDC: 81033-102-52: Case containing 100 unit dose cups of 10 mL packaged in 2 cartons of 50 unit dose cups each
NDC: 81033-102-15: 15 mL unit dose cup
NDC: 81033-102-53: Case containing 100 unit dose cups of 15 mL packaged in 2 cartons of 50 unit dose cups each

STORAGE

Keep tightly closed. Store at controlled room temperature, 20°C to 25°C (68°F to 77°F). [See USP]
Protect from light

QUESTIONS OR COMMENTS

QUESTIONS OR COMMENTS
Call 1-833-537-4679

Packaged by:
Kesin Pharma
Oldsmar, FL 34677
Effective: 09/2024

Rev. 03

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

NDC: 81033-102-51

Guaifenesin Oral Solution, USP

Delivers 100mg per 5mL

FOR INSTITUTIONAL USE ONLY

50 X 5 mL Unit Dose Cups

Store at 59°F to 86°F (15°C to 30°C)

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

NDC: 81033-102-52

Guaifenesin Oral Solution, USP

Delivers 200mg per 10mL

FOR INSTITUTIONAL USE ONLY

50 X 10 mL Unit Dose Cups

Store at 59°F to 86°F (15°C to 30°C)

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

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81033-102-51	50 in 1 CARTON	11/20/2023
1	NDC: 81033-102-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 81033-102-52	50 in 1 CARTON	11/20/2023
2	NDC: 81033-102-10	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/20/2023

Labeler - KESIN PHARMA CORPORATION (117447816)

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

Establishment
Name	Address	ID/FEI	Business Operations
Wittman Pharma, Inc.		830980947	manufacture(81033-102)