DIABETIC TUSSIN NIGHTTIME COLD AND FLU - acetaminophen, dextromethorphan hydrobromide and diphenhydramine hydrochloride 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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Active ingredients (in each 5 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Diphenhydramine HCl 12.5 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
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. 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 5 doses in 24 hours for children under 12 years of age
do not exceed more than 6 doses in 24 hours for adults and children over 12 years of age

adults & children 12 years & over	10 mL (2 teaspoonfuls)
children 6 years to under 12 years	5 mL (1 teaspoonful)
children under 6 years	ask a doctor

Other information

Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
Store at room temperature 20-25°C (68-77°F)

Inactive ingredients

Acesulfame potassium, aspartame, citric acid, hypromellose, menthol, methylparaben, natural & artificial orange flavor, polyethylene glycol, potassium sorbate, propylene glycol, purified water. Sodium citrate 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. 452:02 7/10

Package/Label Principal Display Panel

NDC 61787-452-08

Diabetic Tussin®

DECONGESTANT FREE

Nighttime

Cold & Flu

FEVER, HEADACHE

BODY ACHES, COUGHS

SNEEZING

RUNNY NOSE

Liquid

8 FL OZ (237 mL)

Sodium

Sorbitol

Fructose

& Dyes

ACETAMINOPHEN

DEXTROMETHORPHAN HBr

DIPHENHYDRAMINE HCl

SUGAR & ALCOHOL FREE!

SAFE FOR DIABETICS

SEE NEW WARNINGS INFORMATION

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61787-452
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	325 mg in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg in 5 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
ASPARTAME
ACESULFAME POTASSIUM
HYPROMELLOSE 2910 (4000 MPA.S)
POLYETHYLENE GLYCOL 400
POTASSIUM SORBATE
ANHYDROUS CITRIC ACID
PROPYLENE GLYCOL
METHYLPARABEN
MENTHOL
TRISODIUM CITRATE DIHYDRATE

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE (natural & artificial orange flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:61787-452-04	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		118 mL in 1 BOTTLE	This package is contained within the CARTON (61787-452-04)
2	NDC:61787-452-08	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
2		237 mL in 1 BOTTLE	This package is contained within the CARTON (61787-452-08)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part341	08/01/2010

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: 07/2011 Health Care Products