CHILDRENS TUKOL ACETAMINOPHEN FEVER REDUCER PAIN REDUCER- acetaminophen liquid

Childrens Tukol Acetaminophen Fever Reducer Pain Reducer by

Drug Labeling and Warnings

Childrens Tukol Acetaminophen Fever Reducer Pain Reducer by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA, Inc., AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive ingredient(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily

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

Warnings

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

• more than 5 doses in 24 hours which is the maxium daily amount
• with other drugs containing acetaminophen

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

• skin reddening
• blisters
• rash

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

• with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug containd acetaminophen, ask a doctor or pharmacist

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

• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more tha 3 days
• new symptoms occur
• redness or swelling is present

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 *

• product is not labeled with directions or complete warning for adult use
• Shake well before using
• 1mL = milliliter; tsp = teaspoonful
• find the right dose on chart below. If posssible, use weight to dose: otherwise use age.
• if needed, repeat dose every 4 hours while symptons last
• do not give more than 5 times in 24 hours
• do not give for more than 5 days unless directed by a doctor

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

• each 5 mL (1 tsp) contains: sodium 3 mg
• store between 20-25°C (68-77°F )
• do not refrigerate
• keep carton for complete Drug facts

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.

INGREDIENTS AND APPEARANCE

CHILDRENS TUKOL ACETAMINOPHEN FEVER REDUCER PAIN REDUCER 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-525
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-525-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	05/03/2016

Labeler - Genomma Lab USA, Inc. (832323534)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(50066-525)