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.

agedose
adults and children 12 years and over10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours
children 6 years to under 12 years5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours
children 2 to under 6 years of age2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hours
children under 2 years of ageask 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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50383-063
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ASPARTAME 
HYPROMELLOSE 2910 (4000 MPA.S) 
MENTHOL 
METHYLPARABEN 
POTASSIUM SORBATE 
WATER 
ANHYDROUS CITRIC ACID 
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:50383-063-064 in 1 CASE
1NDC:50383-063-0510 in 1 TRAY
15 mL in 1 CUP, UNIT-DOSE
2NDC:50383-063-0710 in 1 CASE
210 in 1 TRAY
25 mL in 1 CUP, UNIT-DOSE
3NDC:50383-063-114 in 1 CASE
3NDC:50383-063-1010 in 1 TRAY
310 mL in 1 CUP, UNIT-DOSE
4NDC:50383-063-1210 in 1 CASE
410 in 1 TRAY
410 mL in 1 CUP, UNIT-DOSE
5NDC:50383-063-174 in 1 CASE
5NDC:50383-063-1510 in 1 TRAY
515 mL in 1 CUP, UNIT-DOSE
6NDC:50383-063-1810 in 1 CASE
610 in 1 TRAY
615 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/07/2012
Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
NameAddressID/FEIBusiness Operations
Hi-Tech Pharmacal Co., Inc.101196749MANUFACTURE(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.