GUAIFENESIN- guaifenesin solution 
A-S Medication Solutions

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Each 5 mL (1 teaspoonful) contains:

Guaifenesin ................................................ 100 mg

Inactive ingredients

Acesulfame K, artificial cherry & vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

Purpose

Expectorant

Uses

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

Warnings

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, or emphysema

Stop use and ask a doctor if

cough lasts more 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

age

dose

adults and children 12 years and over

10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours

children 6 years to under 12 years

5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours

children 2 to under 6 years of age

2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hours

children under 2 years of age

ask a doctor

How Supplied:

Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose, 15 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottle

Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

STORAGE

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

Questions or comments?

Call 1-800-262-9010.


Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev.063:01 4/13

MG #29850

HOW SUPPLIED

Product: 50090-4856

NDC: 50090-4856-0 10 mL in a CUP, UNIT-DOSE / 10 in a TRAY

GUAIFENESIN SOLUTION

Label Image
GUAIFENESIN 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-4856(NDC:50383-063)
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (artificial cherry flavor) , VANILLA (artificial vanilla flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-4856-010 in 1 TRAY01/21/2020
110 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 finalpart34103/07/2012
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-4856)

Revised: 3/2021
Document Id: 4841af20-c2ba-4393-b00a-1c5f7d786a67
Set id: c4a6dbbc-cbaf-43ce-922a-48289ae624c9
Version: 1
Effective Time: 20210302
 
A-S Medication Solutions