DIABETIC TUSSIN DM- dextromethorphan hydrobromide and guaifenesin liquid

Diabetic Tussin DM by

Drug Labeling and Warnings

Diabetic Tussin DM 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 ingredients (in each 5 mL)

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Purposes

Cough Suppressant

Expectorant

Uses

• temporarily relieves cough
• helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus

Warnings

Do not use

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• a cough that occurs with too much phlegm (mucus)
• a chronic cough that lasts or 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 & over: 10 mL (2 teaspoonfuls)
• children 6 years to under 12 years: 5 mL (1 teaspoonful)
• children 2 years to under 6 years: 2.5 mL (½ 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 20-25ºC (68-77ºF)
• keep tightly closed

Inactive ingredients

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

Questions and 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: 61787-062-04

Diabetic Tussin® DM

Cough Suppressant / Expectorant

Relieves Coughs

Soothes Throat

Relieves Chest Congestion

Liquid

No Sodium, Dye, Codeine, Sorbitol, Fructose

Sugar & Alcohol Free!

Safe for Diabetics

4 Fl. Oz. (118 mL)

INGREDIENTS AND APPEARANCE

DIABETIC TUSSIN DM 
dextromethorphan hydrobromide and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61787-062
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CHERRY (UNII: BUC5I9595W)
VANILLA (UNII: Q74T35078H)
ASPARTAME (UNII: Z0H242BBR1)
HYPROMELLOSE (UNII: 3NXW29V3WO)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61787-062-04	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	05/01/1997

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