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TRIAMINIC

Novartis Consumer Health, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purpose

Antihistamine/cough suppressant

Nasal decongestant

TRIAMINIC Uses

  • temporarily relieves

    Sneezing

    itchy nose or throat

    runny nose

    itchy, watery eyes due to hay fever

    nasal and sinus congestion

    cough due to minor throat and bronchial irritation as may occur with a cold

Warnings

Do not use

  • in a child under 4 years of age
  • in a child who is 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 the child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
  • with any other product containing diphenhydramine, even one used on skin
  • for the purpose of making your child sleepy

Ask a doctor before use if the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts or as occurs with asthma
  • a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers

When using this product

  • do not exceed recommended dosage
  • may cause marked drowsiness
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
  • use enclosed dosing cup only. Keep for use with this product only. Do not use any other dosing device

Age

Dose

children under 4 years of age

do not use

children 4 to under 6 years of age

do not use unless directed by a doctor

children 6 to under 12 years of age

2 teaspoonfuls (10 mL)

TRIAMINIC Other information

  • each teaspoonful contains: sodium 3 mg
  • store at 20-25°C (68°-77°F)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

call 1-800-452-0051

Additional information listed

Child-Resistant Safety Cap.

Do not use if printed neckband is broken or missing.

Distr. by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©20xx

Package/Label Principal Display Panel

TRIAMINIC

Diphenhydramine HCl, Phenylephrine HCl SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0067-8106
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 6.25 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
MALTITOL
propylene glycol
SODIUM BENZOATE
SODIUM CITRATE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:0067-8106-04 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-10-15


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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