DIABETIC TUSSIN DM MAXIMUM STRENGTH- dextromethorphan hydrobromide and guaifenesin liquid

Diabetic Tussin DM Maximum Strength by

Drug Labeling and Warnings

Diabetic Tussin DM Maximum Strength 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 hydrobromide 10 mg

Guaifenesin 200 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 under 12 years of age:

  ask a doctor

Other information

• Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
• store at room temperature 20-25ºC (68-77ºF)
• keep tightly closed

Inactive ingredients

Acesulfame K, artificial cherry & vanilla flavors, aspartame, hypromellose, menthol, methylparaben, polyethylene glycol, potassium sorbate, and 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 #064:03 12/11

Package Principal Display Panel

NDC: 61787-064-08

Diabetic Tussin®

DM MAXIMUM STRENGTH

Cough Suppressant & Expectorant

RELIEVES COUGHS

SOOTHES THROAT

RELIEVES CHEST CONGESTION

Liquid

No Sodium, Dye, Sorbitol, Fructose

SAFE FOR DIABETICS

SUGAR & ALCOHOL FREE!

GLUTEN FREE

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

DIABETIC TUSSIN DM MAXIMUM STRENGTH 
dextromethorphan hydrobromide and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61787-064
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	200 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)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
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: 61787-064-04	1 in 1 BOX	07/03/1995
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 61787-064-08	1 in 1 BOX	07/03/1995
2		237 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	07/03/1995

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(61787-064)