TRIAMINIC FEVER REDUCER- 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, 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.

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)

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 Panel

NDC 0067-6431-04

Children’s Triaminic™ Syrup

2006691

Triaminic Syrup, Grape Flavor

Principal Display - Bubble Gum

NDC 0067-6432-04

Children’s Triaminic™ Syrup

2006702

Triaminic Syrup, Buble Gum Flavor
TRIAMINIC  FEVER REDUCER
acetaminophen syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6431
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 GLYCOLS (UNII: 3WJQ0SDW1A)  
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:0067-6431-041 in 1 CARTON06/01/201010/31/2013
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:0067-6431-011 in 1 CARTON06/01/201010/31/2013
229.57 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 finalpart34306/01/201010/31/2013
TRIAMINIC  FEVER REDUCER
acetaminophen syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6432
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 GLYCOLS (UNII: 3WJQ0SDW1A)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6432-041 in 1 CARTON06/01/201010/31/2013
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:0067-6432-011 in 1 CARTON06/01/201010/31/2013
229.57 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 finalpart34306/01/201010/31/2013
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

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