Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID fb74e8f9-d72f-4681-90bd-df48364405b5
Route
ORAL
Published
Effective Date 2025-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Agave Tequilana Juice Ascorbic Acid Glycerin Sodium Citrate, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

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
Section 42229-5

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
Section 50567-7

When using this product, do not exceed recommended dose (see Overdose warning).

Section 50568-5

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if your child has liver disease.

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give 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; otherwise, use age.

*or as directed by a doctor

Weight (lb) Age (years) 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
Do Not Use
  • with any other drug containing acetaminophen (prescription or nonprescription). 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?

[email protected]

or call 424-235-0355

Other Information
  • Each 5mL contains: sodium 10mg
  • store between 20-25˚C (68-77˚F)
  • do not refrigerate
  • see bottom panel for lot number and expiration date
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. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Inactive Ingredients

Organic agave syrup, non-GMO ascorbic acid (vitamin C), organic cherry flavor, glycerin, natural flavor, non-GMO sodium citrate

DISTRIBUTED BY: KinderFarms®

Redondo Beach, CA 90277 USA

kinderfarms.com

Stop Use and Ask A Doctor If
  • any 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.

Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg

Principal Display Panel 118 Ml Carton Label

KinderMed®

Same active ingredient as

Children's Tylenol®

Ages

2-11 yrs.

KIDS'

PAIN & FEVER

Acetaminophen

160 mg per 5 mL Oral Suspension

Pain Reliever | Fever Reducer

Organic Cherry Flavor

NON

GMO

Project

VERIFIED

nongmoproject.org

NO DYES.

NO ARTIFICIAL FLAVORS.

NO ARTIFICIAL SWEETENERS.

DOSING CUP INCLUDED

4 FL OZ (118 mL)


Structured Label Content

Uses
  • temporarily reduces fever
  • temporarily relieves minor aches and pains due to
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
Section 42229-5 (42229-5)

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
Section 50567-7 (50567-7)

When using this product, do not exceed recommended dose (see Overdose warning).

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if your child has liver disease.

Purpose

Pain reliever/fever reducer

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give 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; otherwise, use age.

*or as directed by a doctor

Weight (lb) Age (years) 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
Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or nonprescription). 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? (QUESTIONS?)

[email protected]

or call 424-235-0355

Other Information (Other information)
  • Each 5mL contains: sodium 10mg
  • store between 20-25˚C (68-77˚F)
  • do not refrigerate
  • see bottom panel for lot number and expiration date
Overdose Warning: (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. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Inactive Ingredients (Inactive ingredients)

Organic agave syrup, non-GMO ascorbic acid (vitamin C), organic cherry flavor, glycerin, natural flavor, non-GMO sodium citrate

DISTRIBUTED BY: KinderFarms®

Redondo Beach, CA 90277 USA

kinderfarms.com

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • any 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.

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

Acetaminophen 160 mg

Principal Display Panel 118 Ml Carton Label (Principal Display Panel - 118 mL Carton Label)

KinderMed®

Same active ingredient as

Children's Tylenol®

Ages

2-11 yrs.

KIDS'

PAIN & FEVER

Acetaminophen

160 mg per 5 mL Oral Suspension

Pain Reliever | Fever Reducer

Organic Cherry Flavor

NON

GMO

Project

VERIFIED

nongmoproject.org

NO DYES.

NO ARTIFICIAL FLAVORS.

NO ARTIFICIAL SWEETENERS.

DOSING CUP INCLUDED

4 FL OZ (118 mL)


Advanced Ingredient Data


Raw Label Data

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