GUAIFENESIN- guaifenesin liquid 
KESIN PHARMA CORPORATION

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Guaifenesin Oral Solution

Guaifenesin

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.

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

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 Guaifenesin 100mg/5mL (Unit Dose Cup 5mL)
NDC 81033-102-10 Guaifenesin 200mg/10mL (Unit Dose Cup 10mL)


STORAGE
Keep tightly closed. Store at 15-30°C (59-86°F)

QUESTIONS OR COMMENTS
Call 1-833-537-4679

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)

5 mL cup label

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)

10 mL cup 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
METHYLPARABEN (UNII: A2I8C7HI9T)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
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
210 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)

Revised: 3/2024
 
KESIN PHARMA CORPORATION