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Triaminic

Novartis Consumer Health, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Triaminic Uses

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • minor sore throat pain
    • toothache
  • temporarily reduces fever

Warnings

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

  • 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

  • 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.

Ask Doctor before use if your child has

  • liver disease

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 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

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 for 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.
Age Weight Dose
under 2 years of age Under 24 lbs ask a doctor
2 to 3 years of age 24-35 lbs 1 teaspoon (5 mL)
4 to 5 years of age 36-47 lbs 1 ½ teaspoons (7.5 mL)
6 to 8 years of age 48-59 lbs 2 teaspoons (10 mL)
9 to 10 years of age 60-71 lbs 2 ½ teaspoons (12.5 mL)
11 years of age 72-95 lbs 3 teaspoons (15 mL)

Triaminic Other information

  • each teaspoonful contains: sodium 5 mg , sodium 6 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, flavor, glycerin, polyethylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucrose

benzoic acid, citric acid, dibasic sodium phosphate, edetate disodium, FD&C red #40, flavor, glycerin, polyethylene glycol, purified water, sorbitol, sucrose

Additional Information Listed on Other Panels

See New Warnings Information

New!

Children’s

Triaminic

Syrup

Fever Reducer

Pain Reliever

Acetaminophen (Pain Reliever/Fever Reducer)

Ages 2-11

TAMPER-EVIDENT FEATURE:

DO NOT USE IF SAFETY SEAL PRINTED WITH “TRIAMINIC”

AROUND BOTTLE CAP IS BROKEN OR MISSING.

  • Alcohol-Free
  • Aspirin-Free
  • Ibuprofen-Free

Triaminic provides a broad range of products, in forms created with the needs of children in mind.

Distr. by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©20XX

call 1-800-452-0051

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

Principal Display - Grape

Triaminic

Principal Display - Bubble Gum

Triaminic

Triaminic

ACETAMINOPHEN SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0067-6431
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
GRAPE
polyethylene glycol
SODIUM BENZOATE
SODIUM CITRATE
sorbitol
SUCROSE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE, PLASTIC
2 29.57 in 1 BOTTLE, PLASTIC
3 NDC:0067-6431-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-06-01


Triaminic

ACETAMINOPHEN SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0067-6432
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg

Inactive Ingredients

Ingredient Name Strength
BENZOIC ACID
CITRIC ACID MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC
EDETATE DISODIUM
FD&C RED NO. 40
GLYCERIN
polyethylene glycol
sorbitol
SUCROSE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE, PLASTIC
2 29.57 in 1 BOTTLE, PLASTIC
3 NDC:0067-6432-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-06-01


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