GUAIFENESIN- guaifenesin solution 
Hi-Tech Pharmacal Co., Inc.

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.

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.063:00 10/10

MG #29850

Package/Label Principal Display Panel

Lid_063_15 mL

Delivers 15 mL

NDC 50383-063-15

GUAIFENESIN ORAL SOLUTION

300 mg/15 mL

Sugar Free/Alcohol Free

EXPECTORANT

SEE INSERT

FOR INSTITUTIONAL USE ONLY

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 063:00 10/10

GUAIFENESIN 
guaifenesin solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50383-063
Route of Administration ORAL DEA Schedule     
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY (artificial cherry flavor) , VANILLA (artificial vanilla flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50383-063-06 4 in 1 CASE
1 NDC:50383-063-05 10 in 1 TRAY
1 5 mL in 1 CUP, UNIT-DOSE
2 NDC:50383-063-07 10 in 1 CASE
2 10 in 1 TRAY
2 5 mL in 1 CUP, UNIT-DOSE
3 NDC:50383-063-11 4 in 1 CASE
3 NDC:50383-063-10 10 in 1 TRAY
3 10 mL in 1 CUP, UNIT-DOSE
4 NDC:50383-063-12 10 in 1 CASE
4 10 in 1 TRAY
4 10 mL in 1 CUP, UNIT-DOSE
5 NDC:50383-063-17 4 in 1 CASE
5 NDC:50383-063-15 10 in 1 TRAY
5 15 mL in 1 CUP, UNIT-DOSE
6 NDC:50383-063-18 10 in 1 CASE
6 10 in 1 TRAY
6 15 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/07/2012
Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
Name Address ID/FEI Business Operations
Hi-Tech Pharmacal Co., Inc. 101196749 MANUFACTURE(50383-063)

Revised: 3/2013
Document Id: 4d939198-a09c-46b0-a8fe-fc2b09b5177d
Set id: 5cb704a7-301c-494e-948f-872ee0d5a289
Version: 2
Effective Time: 20130325
 
Hi-Tech Pharmacal Co., Inc.