DIABETIC TUSSIN DM MAXIMUM STRENGTH - dextromethorphan hydrobromide and guaifenesin liquid 
Health Care Products

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Drug Facts

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)

Storage

• 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.

Package Principal Display Panel

NDC 61787-064-04

Diabetic Tussin®

DM Maximum Strength

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)

DIABETIC TUSSIN DM MAXIMUM STRENGTH  dextromethorphan hydrobromide and guaifenesin   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 61787-064 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 5 mL GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg  in 5 mL

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

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 61787-064-04 1 BOTTLE In 1 BOX contains a BOTTLE 1 118 mL In 1 BOTTLE This package is contained within the BOX (61787-064-04) 2 61787-064-08 1 BOTTLE In 1 BOX contains a BOTTLE 2 237 mL In 1 BOTTLE This package is contained within the BOX (61787-064-08)

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	Operations
Hi-Tech Pharmacal Co., Inc.		101196749	MANUFACTURE

Revised: 09/2010Health Care Products