Triaminic Fever Reducer

Dosage form: syrup
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Novartis Consumer Health, Inc.
NDC Code: 0067-6431

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 ingredient (in each 5 mL, 1 teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

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.
AgeWeightDose
under 2 years of ageUnder 24 lbsask a doctor
2 to 3 years of age24-35 lbs1 teaspoon (5 mL)
4 to 5 years of age36-47 lbs1 ½ teaspoons (7.5 mL)
6 to 8 years of age48-59 lbs2 teaspoons (10 mL)
9 to 10 years of age60-71 lbs2 ½ teaspoons (12.5 mL)
11 years of age72-95 lbs3 teaspoons (15 mL)

Other information
  • each teaspoonful contains: sodium 5 mg <for grape flavor>, sodium 6 mg <for bubblegum flavor>
  • contains no aspirin
  • store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

<for grape flavor>

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

<for bubblegum flavor>

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

Questions or comments?

call 1-800-452-0051

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

Principal Display - Grape

Principal Display - Bubble Gum

TRIAMINIC  FEVER REDUCER
acetaminophen syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6431
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage Description
1NDC:0067-6431-041 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC
2NDC:0067-6431-011 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
229.57 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/2010
TRIAMINIC  FEVER REDUCER
acetaminophen syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6432
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
CITRIC ACID MONOHYDRATE 
SODIUM PHOSPHATE, DIBASIC 
EDETATE DISODIUM 
FD&C RED NO. 40 
GLYCERIN 
POLYETHYLENE GLYCOL 
SORBITOL 
SUCROSE 
WATER 
Packaging
#Item CodePackage Description
1NDC:0067-6432-041 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC
2NDC:0067-6432-011 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
229.57 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/2010
Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 07/2010
 
Novartis Consumer Health, Inc.

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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