Children's Tylenol

Children's Tylenol
SPL v11
SPL
SPL Set ID babcb210-6a47-46ef-b4ea-bdde80411cd3
Route
ORAL
Published
Effective Date 2019-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Sucralose Cellulose Acetate Crospovidone Anhydrous Citric Acid D&c Red No. 7 D&c Red No. 30 Aluminum Oxide Dextrose, Unspecified Form Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Povidone, Unspecified D&c Red No. 33 Fd&c Blue No. 1 Glycerin High Fructose Corn Syrup Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Form Water Sodium Benzoate Sorbitol Solution Xanthan Gum

Identifiers & Packaging

Pill Appearance
Imprint: TY;160;HALF;HALF Shape: round Color: purple Size: 16 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-05-07

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

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

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.

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

Directions
  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (tablets)
or as directed by a doctor
under 24 under 2 years ask a doctor
24-35 lbs 2-3 years 1 tablet
36-47 lbs 4-5 years 1½ tablets
48-59 lbs 6-8 years 2 tablets
60-71 lbs 9-10 years 2½ tablets
72-95 lbs 11 years 3 tablets
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
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
Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Childrens Tylenol

Drug Facts

Other Information
  • store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • do not use if neck band or foil inner seal imprinted with "TYLENOL" is broken or missing
Inactive Ingredients

anhydrous citric acid, cellulose acetate, crospovidone, D&C red no. 7 calcium lake, D&C red no. 30 aluminum lake, dextrose, FD&C blue no. 1 aluminum lake, flavor, magnesium stearate, povidone, sucralose

Questions Or Comments?

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

Principal Display Panel

NDC 50580-460-01

Children's

TYLENOL
®

Acetaminophen (160 mg per 5 mL)

Oral Suspension

Pain Reliever-Fever Reducer

Pain+Fever

Ages 2-11 Years

Ibuprofen Free

Alcohol Free

Aspirin Free

No Parabens

4 fl oz (120 mL)

160 mg per 5 mL




Grape

Flavor

BE READY



AT HOME



OR



ON-THE-GO

Use products only as directed

NDC 50580-460-01

Children's

TYLENOL
®

Acetaminophen

Pain Reliever

Fever Reducer

Pain+Fever

Ages 2-11

Chewables

Chew or crush tablets completely

before swallowing



Ibuprofen Free

Aspirin Free



160 mg

Per Tablet

24

Chewable

Tablets



Actual Size



160 mg each



Grape Flavor

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

Active Ingredient (in Each Chewable Tablet)

Acetaminophen 160 mg


Structured Label Content

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

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.

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

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)
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (tablets)
or as directed by a doctor
under 24 under 2 years ask a doctor
24-35 lbs 2-3 years 1 tablet
36-47 lbs 4-5 years 1½ tablets
48-59 lbs 6-8 years 2 tablets
60-71 lbs 9-10 years 2½ tablets
72-95 lbs 11 years 3 tablets
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
Liver Warning (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
Overdose Warning (Overdose warning)

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Childrens Tylenol

Drug Facts

Other Information (Other information)
  • store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • do not use if neck band or foil inner seal imprinted with "TYLENOL" is broken or missing
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, cellulose acetate, crospovidone, D&C red no. 7 calcium lake, D&C red no. 30 aluminum lake, dextrose, FD&C blue no. 1 aluminum lake, flavor, magnesium stearate, povidone, sucralose

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-460-01

Children's

TYLENOL
®

Acetaminophen (160 mg per 5 mL)

Oral Suspension

Pain Reliever-Fever Reducer

Pain+Fever

Ages 2-11 Years

Ibuprofen Free

Alcohol Free

Aspirin Free

No Parabens

4 fl oz (120 mL)

160 mg per 5 mL




Grape

Flavor

BE READY



AT HOME



OR



ON-THE-GO

Use products only as directed

NDC 50580-460-01

Children's

TYLENOL
®

Acetaminophen

Pain Reliever

Fever Reducer

Pain+Fever

Ages 2-11

Chewables

Chew or crush tablets completely

before swallowing



Ibuprofen Free

Aspirin Free



160 mg

Per Tablet

24

Chewable

Tablets



Actual Size



160 mg each



Grape Flavor

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

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Acetaminophen 160 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)