Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID f33db02a-58f4-41a5-8f1f-4ec64d17f5a1
Route
ORAL
Published
Effective Date 2024-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Agave Tequilana Juice Citric Acid Monohydrate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-27

Description

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

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

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

  • skin reddening
  • blisters
  • rash

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

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.

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not take more than directed (see overdose warning)
  • shake well before using
  • mL= milliliter
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
  • find the right dose on chart below. If possible, use weight to dose, use age.
Weight (lb) Age (year) Dose (mL)*

 under 24 under 2 ask a doctor
 24-35 2-3 5 mL
 36-47 4-5  7.5 ml
 48-59 6-8 10 mL
 60-71 9-10 12.5 mL
 72-95 11 15 mL

*or as directed by a doctor

Do Not Use
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product
Questions?

Call 424-235-0355

Product Label
KINDERMED Kids Pain & Fever Cherry Flavor
Other Information
  • store between 20-25ºC (68-77ºF)
  • do not refrigerate
  • see bottom panel for lot number and expiration date
Inactive Ingredient

Organic agave syrup, non-GMO citric acid, organic natural flavors, purified water

Principal Display Panel

KIDS' PAIN & FEVER Ages 2 to 11 yrs

Acetaminophen

160 mg per 5 mL

Pain Reliever | Fever Reducer

Oral Suspension

Organic Cherry Flavor

NO COMMON ALLERGENS.

NO DYES OR PARABENS.

FL OZ (mL)

DOSING CUP INCLUDED

TAMPER EVIDENT: BOTTLE IS SAFETY SEALED WITH A PERFORATED BAND AROUND  BOTTLE. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.

Keep outer carton for complete warnings and product information.

DISTRIBUTED BY: KinderFarms®

Redondo Beach, CA 90277 USA

kinderfarms.com

When Using This Product
  • do not exceed recommended dosage (see overdose warning).
Stop Use and Ask A Doctor If
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

Keep Out of Reach of Children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg

Ask A 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.


Structured Label Content

Uses
  • temporarily reduces fever
  • temporarily 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 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

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

  • skin reddening
  • blisters
  • rash

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

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.

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not take more than directed (see overdose warning)
  • shake well before using
  • mL= milliliter
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
  • find the right dose on chart below. If possible, use weight to dose, use age.
Weight (lb) Age (year) Dose (mL)*

 under 24 under 2 ask a doctor
 24-35 2-3 5 mL
 36-47 4-5  7.5 ml
 48-59 6-8 10 mL
 60-71 9-10 12.5 mL
 72-95 11 15 mL

*or as directed by a doctor

Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product
Questions?

Call 424-235-0355

Product Label
KINDERMED Kids Pain & Fever Cherry Flavor
Other Information (Other information)
  • store between 20-25ºC (68-77ºF)
  • do not refrigerate
  • see bottom panel for lot number and expiration date
Inactive Ingredient (Inactive ingredient)

Organic agave syrup, non-GMO citric acid, organic natural flavors, purified water

Principal Display Panel

KIDS' PAIN & FEVER Ages 2 to 11 yrs

Acetaminophen

160 mg per 5 mL

Pain Reliever | Fever Reducer

Oral Suspension

Organic Cherry Flavor

NO COMMON ALLERGENS.

NO DYES OR PARABENS.

FL OZ (mL)

DOSING CUP INCLUDED

TAMPER EVIDENT: BOTTLE IS SAFETY SEALED WITH A PERFORATED BAND AROUND  BOTTLE. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.

Keep outer carton for complete warnings and product information.

DISTRIBUTED BY: KinderFarms®

Redondo Beach, CA 90277 USA

kinderfarms.com

When Using This Product (When using this product)
  • do not exceed recommended dosage (see overdose warning).
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

Keep Out of Reach of Children. (Keep out of reach of children.)

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Acetaminophen 160 mg

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

liver disease.

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

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

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