DIABETIC TUSSIN EXPECTORANT- guaifenesin liquid

Diabetic Tussin Expectorant by

Drug Labeling and Warnings

Diabetic Tussin Expectorant by is a Otc medication manufactured, distributed, or labeled by Health Care Products, Hi-Tech Pharmacal Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 (½ - 1 teaspoonful)

• children under 2 years:

  ask a doctor

Other information

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

Rev #063:05 10/11

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)

INGREDIENTS AND APPEARANCE

DIABETIC TUSSIN EXPECTORANT 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61787-063
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, UNSPECIFIED (UNII: 3NXW29V3WO)
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: 61787-063-04	1 in 1 BOX	01/01/1996
1		118 mL in 1 BOTTLE; 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	01/01/1996

Labeler - Health Care Products (101196749)

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

Establishment
Name	Address	ID/FEI	Business Operations
Hi-Tech Pharmacal Co., Inc.		101196749	MANUFACTURE(61787-063)