DIABETIC TUSSIN NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, and diphenhydramine hcl liquid 
MEDTECH PRODUCTS INC

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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Diabetic Tussin Nighttime Cold and Flu 61787-516

Drug Facts

Active ingredients (in each 10 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Diphenhydramine HCl 25 mg

Purposes

Pain Relief

Cough Suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms including:

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use

if the user is taking the blood thinning drug warfarin, tranquilizers or sedatives.

When using this product:

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in small children

Stop use and ask a doctor if

  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • cough comes back or occurs with 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. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

Adults10 mL (2 teaspoons)
Children under 12 yearsask a doctor

Other information

Inactive ingredients

Acesulfame potassium, artificial raspberry flavor, hypromellose, menthol, methylparaben, polyethylene glycol, potassium sorbate, propylene glycol, purified water, and sucralose. Citric acid may be used to adjust pH.

Questions or comments?

Call: 1-800-579-8327, serious side effects associated with use of this product may be reported to this number.

Package/Label Principal Display Panel

SUGAR & ALCOHOL FREE!

Specifically Formulated for Diabetics

Diabetic Tussin®

NIGHTTIME

COLD & FLU

Acetaminophen (Pain Relief)

Dextromethorphan HBr (Cough Suppressant)

Diphenhydramine HCl (Antihistamine)

Relieves:

Improved Berry Flavor 

4 FL OZ (118 mL)

SUGAR & ALCOHOL FREE!
Specifically Formulated for Diabetics
Diabetic Tussin®
NIGHTTIME
COLD & FLU
Acetaminophen (Pain Relief)
Dextromethorphan HBr (Cough Suppressant)
Diphenhydramine HCl (Antihistamine)
Relieves:
• Cough
• Sore throat
• Runny nose & sneezing
• Minor aches & pains
• Headache
• Fever
Improved Berry Flavor 
4 FL OZ (118 mL)

DIABETIC TUSSIN NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, and diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-516
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
RASPBERRY (UNII: 4N14V5R27W)  
WATER (UNII: 059QF0KO0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
Color    Score    
ShapeSize
FlavorRASPBERRY (artificial raspberry flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61787-516-041 in 1 CARTON02/01/2020
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/01/2020
Labeler - MEDTECH PRODUCTS INC (114707784)
Establishment
NameAddressID/FEIBusiness Operations
Akorn Operating Company LLC (dba Akorn)117696873manufacture(61787-516)

Revised: 3/2022
Document Id: 3f09d224-c1f3-43fc-a177-c3d4d84ae725
Set id: 4d5e317f-0e32-4cdc-b56e-b792efa972f5
Version: 3
Effective Time: 20220303
 
MEDTECH PRODUCTS INC