Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 81cc4900-226b-4c49-ba9c-5747d2a501b1
Route
ORAL
Published
Effective Date 2025-05-29
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 50566-9

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.

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
  • only use the enclosed syringe.

    Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • remove cap, insert syringe into hole at top of bottle until it snaps into place and turn upside down
  • pull back syringe until filled to the prescribed level. If you pass the prescribed level, invert assembly to right side up on flat surface and simply push syringe back until you have reached the correct dose. Slowly dispense the liquid into your child's mouth (towards inner cheek).
  • 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
  • replace cap tightly to maintain child resistance
  • 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
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

Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg

Principal Display Panel 59 Ml Carton Label

KinderMed®

Same active ingredient as

Infants' Tylenol® for Children

For Children

Ages 2-3 yrs.

INFANTS'

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.

SYRINGE INCLUDED

2 FL OZ (59 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 50566-9 (50566-9)

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.

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
  • only use the enclosed syringe.

    Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • remove cap, insert syringe into hole at top of bottle until it snaps into place and turn upside down
  • pull back syringe until filled to the prescribed level. If you pass the prescribed level, invert assembly to right side up on flat surface and simply push syringe back until you have reached the correct dose. Slowly dispense the liquid into your child's mouth (towards inner cheek).
  • 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
  • replace cap tightly to maintain child resistance
  • 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
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

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

Acetaminophen 160 mg

Principal Display Panel 59 Ml Carton Label (Principal Display Panel - 59 mL Carton Label)

KinderMed®

Same active ingredient as

Infants' Tylenol® for Children

For Children

Ages 2-3 yrs.

INFANTS'

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.

SYRINGE INCLUDED

2 FL OZ (59 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)