Children's Tukol® Fever Pain  525

Children's Tukol® Fever Pain  525
SPL v1
SPL
SPL Set ID 0540111a-fcde-492d-9ed5-bbd714b2acf0
Route
ORAL
Published
Effective Date 2017-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid Butylparaben Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Microcrystalline Cellulose Carboxymethylcellulose Sodium Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-05-03

Description

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

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.

Attention:

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

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
Drug Facts

Acetaminophen 160 mg

Questions?

Call 1-877-99-GENOM (43666)

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

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
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.

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

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.

Ask A Doctor Before Use If the Child Has

liver disease

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.

Ask A Doctor Or Pharmacist Before Use If the Child Is

taking the blood thinning drug warfarin.


Structured Label Content

Uses

temporarily

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

Pain reliever/fever reducer

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.

Attention:

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

Do Not Use (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
Drug Facts

Acetaminophen 160 mg

Questions?

Call 1-877-99-GENOM (43666)

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

Other Information (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
Overdose Warning: (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.

Inactive Ingredients (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

When Using This Product (When using this product)

do not exceed recommended dose (see overdose warning)

Stop Use and Ask A Doctor If (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.)

Keep out of reach of children.

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)

liver disease

Children's Tukol® Fever Pain Product Label (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.

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

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