Triaminic description, usages, side effects, indications, overdosage, supplying and lots more!

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Triaminic

Novartis Consumer Health, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Dextromethorphan HBr 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Triaminic Uses

  • temporarily relieves minor aches and pains
    • minor aches and pains
    • headache
    • minor sore throat pain
    • cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily reduces fever

Warnings

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

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • in a child under 4 years of age
  • if your child is allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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 your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

  • liver disease
  • chronic cough that lasts, or as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if your child is

  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough 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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • may be given every 4 hours. Do not give more than 5 doses in 24 hours unless directed by a doctor.
  • find the right dose on chart below.
  • 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 under 4 to under 6 years of age

1 teaspoonful (5 mL)

Children under 6 to under 12 years of age

2 teaspoonful (10 mL)

Triaminic Other information

  • each teaspoonful contains: sodium 5 mg
  • contains no aspirin
  • store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucrose

Questions or comments?

call 1-800-452-0051

Additional information listed on other panels

PARENTS: Learn about teen medicine abuse.
www.StopMedicineAbuse.org

Child-Resistant Safety Cap

TAMPER-EVIDENT FEATURE:

DO NOT USE IF SAFETY SEAL IMPRINTED WITH “TRIAMINIC”

AROUND BOTTLE CAP IS BROKEN OR MISSING.

Triaminic® Has More Ways to Help Kids Feel Better.

Great Tasting Liquids

  • Free Dosage Cup (enclosed)
  • Alcohol - Free

Thin Strips®

  • Melts in an Instant
  • Easy to Give/Easy to Take
  • No Mess Dosing

What You Need to Make Your Child Feel Better!

For more information plus helpful tips visit www.triaminic.com

Distr. by: Novartis Consumer Health, Inc .
Parsippany, NJ 07054-0622 ©20XX

Principal Display Panel

0067-6348-04

Children’s Triaminic® Syrup
Cough & Sore Throat

Acetaminophen ( Pain Reliever/Fever Reducer)
Dextromethorphan
HBr (Cough Suppressant)

  • Cough
  • Sore Throat

Grape FLAVOR

Triaminic

Acetaminophen, Dextromethorphan HBr SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0067-6348
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
POLYETHYLENE GLYCOL 1450
water
SODIUM BENZOATE
SODIUM CITRATE
sorbitol
Sucralose

Product Characteristics

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:0067-6348-04 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2008-09-06


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Be sure to consult your doctor before taking any medication!
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