Guaifenesin by Hi-Tech Pharmacal Co., Inc. GUAIFENESIN solution

Guaifenesin by

Drug Labeling and Warnings

Guaifenesin by is a Otc medication manufactured, distributed, or labeled by Hi-Tech Pharmacal Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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. 063:01 4/13

INGREDIENTS AND APPEARANCE

GUAIFENESIN 
guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50383-063
Route of Administration	ORAL

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, UNSPECIFIED FORM (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	03/07/2012
1	NDC: 50383-063-05	10 in 1 TRAY
1		5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 50383-063-07	10 in 1 CASE	03/07/2012
2		10 in 1 TRAY
2		5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
3	NDC: 50383-063-11	4 in 1 CASE	03/07/2012
3	NDC: 50383-063-10	10 in 1 TRAY
3		10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
4	NDC: 50383-063-12	10 in 1 CASE	03/07/2012
4		10 in 1 TRAY
4		10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
5	NDC: 50383-063-17	4 in 1 CASE	03/07/2012
5	NDC: 50383-063-15	10 in 1 TRAY
5		15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
6	NDC: 50383-063-18	10 in 1 CASE	03/07/2012
6		10 in 1 TRAY
6		15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

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)