Diabetic Tussin Nighttime Cold and Flu

Dosage form: liquid
Ingredients: ACETAMINOPHEN 325mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL, DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL
Labeler: Health Care Products
NDC Code: 61787-452

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.

Drug Facts

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 & over10 mL (2 teaspoonfuls)
children 6 years to under 12 years5 mL (1 teaspoonful)
children under 6 yearsask 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. 452:04 12/11

Package/Label Principal Display Panel

NDC 61787-452-04

Diabetic Tussin®

DECONGESTANT FREE

Nighttime

Cold & Flu

FEVER, HEADACHE

BODY ACHES

COUGHS

SNEEZING

RUNNY NOSE

Liquid

NO

Sodium

Sorbitol

Fructose

& Dyes

ACETAMINOPHEN

DEXTROMETHORPHAN HBr

DIPHENHYDRAMINE HCl

SAFE FOR DIABETICS

SUGAR & ALCOHOL FREE!

GLUTEN FREE

 

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:61787-452
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorBROWN (clear, colorless to light brown) Score    
ShapeSize
FlavorORANGE (natural & artificial orange flavor) , MENTHOLImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:61787-452-041 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:61787-452-081 BOTTLE in 1 CARTON
2237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/2010
Labeler - Health Care Products (101196749)
Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
NameAddressID/FEIOperations
Hi-Tech Pharmacal Co., Inc.101196749MANUFACTURE(61787-452)

Revised: 09/2012
 
Health Care Products

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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