Skip to Content

← See all Guaifenesin brands

Guaifenesin by Hi-Tech Pharmacal Co., Inc.

Medically reviewed on March 26, 2018

Dosage form: solution
Ingredients: GUAIFENESIN 100mg in 5mL
Labeler: Hi-Tech Pharmacal Co., Inc.
NDC Code: 50383-063

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.

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
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

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 DRUGItem 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 Description
1NDC:50383-063-064 TRAY in 1 CASE
1NDC:50383-063-0510 CUP, UNIT-DOSE in 1 TRAY
15 mL in 1 CUP, UNIT-DOSE
2NDC:50383-063-0710 TRAY in 1 CASE
210 CUP, UNIT-DOSE in 1 TRAY
25 mL in 1 CUP, UNIT-DOSE
3NDC:50383-063-114 TRAY in 1 CASE
3NDC:50383-063-1010 CUP, UNIT-DOSE in 1 TRAY
310 mL in 1 CUP, UNIT-DOSE
4NDC:50383-063-1210 TRAY in 1 CASE
410 CUP, UNIT-DOSE in 1 TRAY
410 mL in 1 CUP, UNIT-DOSE
5NDC:50383-063-174 TRAY in 1 CASE
5NDC:50383-063-1510 CUP, UNIT-DOSE in 1 TRAY
515 mL in 1 CUP, UNIT-DOSE
6NDC:50383-063-1810 TRAY in 1 CASE
610 CUP, UNIT-DOSE 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/FEIOperations
Hi-Tech Pharmacal Co., Inc.101196749MANUFACTURE(50383-063)

 
Hi-Tech Pharmacal Co., Inc.

← See all Guaifenesin brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide