TRIAMINIC INFANTS FEVER REDUCER PAIN RELIEVER GRAPE- acetaminophen syrup 
TRIAMINIC INFANTS FEVER REDUCER PAIN RELIEVER BUBBLEGUM- acetaminophen syrup 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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.

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Drug Facts

Active ingredient(in each 5 mL)

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 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

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.
find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
use only enclosed dosing syringe designed for use with this product. Do not use any other dosing device.

Weight

Age

Dose

Under 24 lbs

under 2 years of age

ask a doctor

24-35 lbs

2 to 3 years of age

5.0 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

Questions or comments?

call 1-800-452-0051

Additional Information Listed on Other Panels

Infants’

Triaminic

Syrup

Fever Reducer

Pain Reliever

Acetaminophen 160 mg per 5 mL

(Pain Reliever/Fever Reducer)

Ages 2-3

Under 2 years-ask a doctor

Use with enclosed syringe ONLY

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
1.
We provide 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

Principal Display Panel

NDC 0067-6440-59

Infants’ Triaminic

Fever Reducer

Pain Reliever

Grape

FLAVOR

©2011

2007944

Triaminic Infant APAP Syrup Carton- grape flavor

Principal Display - Bubble Gum

NDC 0067-6441-59

Infants’ Triaminic

Fever Reducer

Pain Reliever

Bubble Gum

FLAVOR

©2011

2007943

Triamin Infant APAP Syrup Carton- Bubblegum Flavor
TRIAMINIC  INFANTS FEVER REDUCER PAIN RELIEVER GRAPE
acetaminophen syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6440
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
GRAPE (UNII: 6X543N684K)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6440-591 in 1 CARTON09/26/201210/31/2013
159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/26/201210/31/2013
TRIAMINIC  INFANTS FEVER REDUCER PAIN RELIEVER BUBBLEGUM
acetaminophen syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6441
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6441-591 in 1 CARTON09/26/201210/31/2013
159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/26/201210/31/2013
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 10/2016
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC