CHILDRENS TUKOL ACETAMINOPHEN FEVER REDUCER PAIN REDUCER- acetaminophen liquid 
Genomma Lab USA, Inc.

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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Children's Tukol® Fever Pain  525

Drug Facts
Active ingredient
(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily

Warnings

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If skin reaction occurs, stop use and seek medical help right away.

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

Do not use

Ask a doctor before use if the child has

liver disease

Ask a doctor or pharmacist before use if the child is

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

These could be signs of a serious condition

Keep out of reach of children.

Keep out of reach of children.

Overdose warning:

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions *

weight (lb)             age                             dose (mL or tsp)

under  24              under 2 years              ask a doctor

24 - 35                  2 - 3 years                  5 mL (1 tsp)

36- 47                   4 - 5 years                   7.5 mL (1 1/2 tsp)

48 - 59                  6 - 8 years                  10 mL (10 mL (2 tsp)

60- 71                   9 - 10 years                 12.5 mg  (2 1/2 tsp)

72 95                    11 years                       15 mL (3 tsp)

use only enclosed dosing cup specfically designed for use with this product

Attention:

use only enclosed dosing cup specfically designed for use with this product

Other information

Inactive ingredients

anhydrous citric acid, butylparaben, FD&C red # 40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions?

Call 1-877-99-GENOM (43666)

Children's Tukol® Fever Pain product label

Children's Tukol®

Acetaminophen - Pain Reliever-Fever Reducer Oral Suspension

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSION

NEW

Ages 2 - 11

Fever Reducer

Pain Reducer

CHERRY FLAVOR

4 FL OZ (118 mL)
160 mg per 5 mL

Distributer by
Genomma Lab USA Inc.,
Houston, TX 77027

BX--058

LOT No.

Exp.

AptaPharmTukol FeverPain 525

AptaPharmTukol FeverPain 525

CHILDRENS TUKOL ACETAMINOPHEN FEVER REDUCER PAIN REDUCER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-525
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-525-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/03/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/03/2016
Labeler - Genomma Lab USA, Inc. (832323534)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(50066-525)

Revised: 4/2017
Document Id: abbc3017-0f3f-4c00-aa6f-c5786b17b423
Set id: 0540111a-fcde-492d-9ed5-bbd714b2acf0
Version: 1
Effective Time: 20170415
 
Genomma Lab USA, Inc.