DIABETIC TUSSIN EXPECTORANT - guaifenesin liquid
Health Care Products

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Drug Facts

Active ingredient (in each 5 mL)

Guaifenesin 100 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus

Warnings

Ask a doctor before use if you have:

a cough that occurs with too much phlegm (mucus)
a persistent or chronic cough 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 occurs with fever, rash, or headache that lasts

These could be signs of a serious condition.

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.

Directions

take every 4 hours
do not exceed 6 doses in 24 hours

adults & children 12 years and over	10 mL - 20 mL (2 - 4 teaspoonfuls)
children 6 years to under 12 years	5 mL - 10 mL (1 - 2 teaspoonfuls)
children 2 years to under 6 years	2.5 mL - 5 mL (1/2 - 1 teaspoonful)
children under 2 years	ask a doctor

Other information

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

Storage

Store at room temperature 20 -25°C (68 -77°F).

Keep tightly closed.

Inactive ingredients

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

Questions or comments?

Call 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number.

Package/Label Principal Display Panel

NDC 61787-063-04

Diabetic Tussin®

Guaifenesin 100 mg/5 mL

Expectorant

Loosens & Relieves Chest Congestion

Thins & Loosens Mucus

Liquid

No Sodium, Sorbitol, Fructose & Dyes

Sugar & Alcohol Free!

Safe for Diabetics

4 Fl.Oz. (118 mL)

Package/Label Principal Display Panel

NDC 61787-063-04

Diabetic Tussin®

Guaifenesin 100 mg/5 mL

Expectorant

Loosens & Relieves Chest Congestion

Thins & Loosens Mucus

Liquid

No Sodium, Sorbitol, Fructose & Dyes

Sugar & Alcohol Free!

Safe for Diabetics

4 Fl.Oz. (118 mL)

DIABETIC TUSSIN EXPECTORANT
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	61787-063
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (GUAIFENESIN)	GUAIFENESIN	100 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM
CHERRY
VANILLA
ASPARTAME
HYPROMELLOSE
MENTHOL
METHYLPARABEN
POTASSIUM SORBATE
WATER
ANHYDROUS CITRIC ACID

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	61787-063-04	1 BOTTLE In 1 BOX	contains a BOTTLE
1		118 mL In 1 BOTTLE	This package is contained within the BOX (61787-063-04)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/1996

Labeler - Health Care Products (101196749)

Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)

Establishment
Name	Address	ID/FEI	Operations
Hi-Tech Pharmacal Co., Inc.		101196749	MANUFACTURE

Revised: 09/2010Health Care Products