infants' tylenol

infants' tylenol
SPL v10
SPL
SPL Set ID 2143cc16-86db-4060-96da-5c228ae9207b
Route
oral
Published
Effective Date 2020-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (160 mg)
Inactive Ingredients
d&c red no. 33 fd&c blue no. 1 glycerin high fructose corn syrup microcrystalline cellulose anhydrous citric acid carboxymethylcellulose sodium, unspecified form water sodium benzoate sorbitol solution sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
otc monograph drug active Since 2017-08-07

Purpose

Pain reliever/fever reducer

Description

Drug Facts


Medication Information

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
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
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
  • push air out of syringe. Insert syringe tip into bottle opening
  • flip bottle upside down. Pull yellow part of syringe to correct dose
  • dispense liquid slowly into child's mouth, toward inner cheek
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • replace cap tightly to maintain child resistance
Dosing Chart
Weight (lb) Age (yr) Dose (mL)
or as directed by a doctor
under 24 under 2 years ask a doctor
24-35 lbs 2-3 years 5 mL

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Other Information
  • store between 20-25°C (68-77°F)
  • do not use if carton tape or bottle wrap imprinted with "TYLENOL" is broken or missing
Inactive Ingredients

anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Description

Drug Facts

Principal Display Panel

NDC 50580-433-01

Infants'

TYLENOL ®

For Children

Acetaminophen 160 mg per 5 mL Oral Suspension

Pain Reliever-Fever Reducer

Pain + Fever

Infants

Alcohol Free

Ibuprofen Free

Aspirin Free

No Parabens

SimpleMeasure ®

Specially designed for younger children

Use Only Enclosed Syringe

1 fl oz (30 mL)

160 mg per 5 mL*

Grape Flavor

*Same as Children's TYLENOL

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

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 Or Comments?

call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)

Stop Use and Ask A Doctor If
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg


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

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
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
  • push air out of syringe. Insert syringe tip into bottle opening
  • flip bottle upside down. Pull yellow part of syringe to correct dose
  • dispense liquid slowly into child's mouth, toward inner cheek
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • replace cap tightly to maintain child resistance
Dosing Chart
Weight (lb) Age (yr) Dose (mL)
or as directed by a doctor
under 24 under 2 years ask a doctor
24-35 lbs 2-3 years 5 mL

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • do not use if carton tape or bottle wrap imprinted with "TYLENOL" is broken or missing
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-433-01

Infants'

TYLENOL ®

For Children

Acetaminophen 160 mg per 5 mL Oral Suspension

Pain Reliever-Fever Reducer

Pain + Fever

Infants

Alcohol Free

Ibuprofen Free

Aspirin Free

No Parabens

SimpleMeasure ®

Specially designed for younger children

Use Only Enclosed Syringe

1 fl oz (30 mL)

160 mg per 5 mL*

Grape Flavor

*Same as Children's TYLENOL

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

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 Or Comments? (Questions or comments?)

call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)

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 than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

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

Acetaminophen 160 mg


Advanced Ingredient Data


Raw Label Data

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