DIABETIC TUSSIN DM MAXIMUM STRENGTH- dextromethorphan hydrobromide and 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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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)
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

Image of Carton - 237 mL

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)

DIABETIC TUSSIN DM MAXIMUM STRENGTH 
dextromethorphan hydrobromide and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-064
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRY (artificial cherry flavor) , VANILLA (artificial vanilla flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61787-064-041 in 1 BOX07/03/1995
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:61787-064-081 in 1 BOX07/03/1995
2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/03/1995
Labeler - Health Care Products (101196749)
Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
NameAddressID/FEIBusiness Operations
Hi-Tech Pharmacal Co., Inc.101196749MANUFACTURE(61787-064)

Revised: 12/2019
Document Id: 39f7ba09-bc2d-4998-b27e-1549ea325fba
Set id: 9708c338-f00e-4fc2-a759-44b65db0860d
Version: 3
Effective Time: 20191217
 
Health Care Products