GUAIFENESIN- guaifenesin liquid 
KESIN PHARMA CORPORATION

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Guaifenesin Oral Solution, USP

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

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. 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

AgeDose
Adults and children 12 years and over10 to 20mL (2 to 4 teaspoonfuls) every 4 hours
Children 6 years to under 12 years5 to 10mL (1 to 2 teaspoonfuls) every 4 hours
Children 2 to under 6 years of age2.5 to 5mL (1/2 to 1 teaspoonful) every 4 hours
Children under 2 years of ageConsult 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

Kesin Pharma Logo

Packaged by:
Kesin Pharma

Oldsmar, FL 34677
Effective: 09/2024

Rev. 03

5 mL Unit Dose Cup Case Label

NDC 81033-102-51

Guaifenesin Oral Solution, USP100 mg/5 mL

Delivers 5 mL

Case = 100 UD Cups (Do Not Break Case)

Store at 68°F to 77°F (20°C to 25°C)

QTY 1

Guaifenesin Oral Solution 5 mL Case Label

10 mL Unit Dose Cup Case Label

NDC 81033-102-52

Guaifenesin Oral Solution, USP 200 mg/10 mL

Delivers 10 mL

Case = 100 UD Cups (Do Not Break Case)

Store at 68°F to 77°F (20°C to 25°C)

QTY 1

Guaifenesin Oral Solution 10 mL Case Label

15 mL Unit Dose Cup Case Label

NDC 81033-102-53

Guaifenesin Oral Solution, USP 300 mg/15 mL

Delivers 15 mL

Case = 100 UD Cups (Do Not Break Case)

QTY 1 Guaifenesin Oral Solution 15 mL Case Label

GUAIFENESIN 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81033-102
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81033-102-5150 in 1 CARTON11/20/2023
1NDC:81033-102-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:81033-102-5250 in 1 CARTON11/20/2023
2NDC:81033-102-1010 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/20/2023
Labeler - KESIN PHARMA CORPORATION (117447816)
Establishment
NameAddressID/FEIBusiness Operations
Kesin Pharma117447816pack(81033-102) , label(81033-102)
Establishment
NameAddressID/FEIBusiness Operations
Belleview Biosciences131968803manufacture(81033-102) , label(81033-102) , analysis(81033-102)

Revised: 3/2025
Document Id: 316ac9e6-8d03-f55a-e063-6294a90a8540
Set id: 365c01b7-a197-4876-85fc-42204f787e3a
Version: 7
Effective Time: 20250328
 
KESIN PHARMA CORPORATION