Diabetic Tussin Nighttime Cold And Flu
FDA Label NDC 61787-452

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Health Care Products for the product Diabetic Tussin Nighttime Cold And Flu (NDC 61787-452). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each 5 ml), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use, when using this product:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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. 452:04 12/11

Package/Label Principal Display Panel

Image Of Carton (118 mL)

Image Of Carton (118 mL)

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)

 

 

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