DIABETIC TUSSIN MUCUS RELIEF- guaifenesin liquid
Health Care Products

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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Active ingredient (in each 5 mL)

Guaifenesin 200 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus
helps make coughs more productive

Warnings

Ask a doctor before use if you have:

a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
a cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if:

symptoms are accompanied by fever, rash, or persistent headache
cough persists for more than 1 week or tends to recur

A persistent cough may be a sign 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 & over	5 mL - 10 mL (1 - 2 teaspoonfuls)
children 6 years to under 12 years	2.5 mL - 5 mL (1/2 - 1 teaspoonful)
children 2 years to under 6 years	1.25 mL - 2.5 mL (1/4 - 1/2 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

Aspartame, benzoic acid, hydroxyethyl cellulose, menthol, natural & artificial blueberry flavor, polyethylene glycol, propylene glycol, purified water, sucralose. Citric acid / potassium hydroxide 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 Principal Display Panel

NDC 61787-446-04

Diabetic Tussin Ⓡ

Guaifenesin 200 mg/5 mL

Expectorant

Mucus Relief

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 MUCUS RELIEF
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61787-446
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (GUAIFENESIN)	GUAIFENESIN	200 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME
BENZOIC ACID
HYDROXYETHYL CELLULOSE (4000 CPS AT 1%)
MENTHOL
BLUEBERRY
POLYETHYLENE GLYCOL 400
WATER
SUCRALOSE
ANHYDROUS CITRIC ACID
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE

Packaging
#	Item Code	Package Description
1	NDC:61787-446-04	1 in 1 BOX
1		118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/01/2007

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

Revised: 09/2010

Document Id: e27f01a2-49fa-407b-ab4b-7c457268a442

Set id: e27f01a2-49fa-407b-ab4b-7c457268a442

Version: 1

Effective Time: 20100907

Health Care Products