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

Diabetic Tussin Nighttime Cold and Flu by

Drug Labeling and Warnings

Diabetic Tussin Nighttime Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Akorn Consumer Health, Hi-Tech Pharmacal Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches and pains
• muscular aches
• fever
• runny nose and sneezing

Warnings

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

• adults take more than 6 doses in 24 hours, which is the maximum daily amount
• child takes more than 5 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks everyday while using this product

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

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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 2 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.
• with any other product containing diphenhydramine, even one used on the skin

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

• take every 4 to 6 hours
• do not exceed more than 6 doses in 24 hours for adults and children over 12 years of age

• Adults:

  10 mL (2 teaspoons)

• Children under 12 years:

  ask a doctor

Other information

• Store at room temperature 20-25°C (68-77°F)

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.

Rev. 516:00 04/19

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:

• Cough
• Sore throat
• Runny nose & sneezing
• Minor aches & pains
• Headache
• Fever

Improved Berry Flavor 

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

DIABETIC TUSSIN NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, and diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61787-516
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 10 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	RASPBERRY (artificial raspberry flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61787-516-04	1 in 1 CARTON	02/01/2020
1		118 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	02/01/2020

Labeler - Akorn Consumer Health (101196749)

Establishment
Name	Address	ID/FEI	Business Operations
Hi-Tech Pharmacal Co., Inc.		101196749	MANUFACTURE(61787-516)