Equate 44-450-children

Equate 44-450-children
SPL v14
SPL
SPL Set ID 1729d4b1-ca3b-4360-8328-2484f239440a
Route
ORAL
Published
Effective Date 2025-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Citric Acid Monohydrate Crospovidone, Unspecified D&c Red No. 27 Aluminum Lake D&c Red No. 30 Aluminum Lake Dextrose Monohydrate Ethylcellulose, Unspecified Magnesium Stearate Mannitol High Density Polyethylene Stearic Acid Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: 44;450 Shape: round Color: pink Size: 16 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2005-02-25

Description

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • sore throat
    • flu
    • toothache
    • the common cold
  • temporarily reduces fever
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 give more than directed
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (chewable tablets)*
Under 24 Under 2 Ask a doctor
24-35 2-3 1 tablet
36-47 4-5 1 1/2 tablets
48-59 6-8 2 tablets 
60-71 9-10 2 1/2 tablets
72-95 11 3 tablets 

*or as directed by a doctor

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.



Other Information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • avoid high humidity
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients

citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions Or Comments?

1-888-287-1915

Principal Display Panel

equate™

NDC 49035-777-08

Compare to

Children's

Tylenol® Chewables active

ingredient

children's 

PAIN & FEVER

Acetaminophen 160 mg

Chewable Tablets

■  Pain Reliever / Fever Reducer

2-11 YEARS

■ Aspirin Free

■ Ibuprofen Free

Bubblegum Flavor

24 Chewable Tablets

Actual Size

Chew or crush

tablets completely

before swallowing.

TAMPER EVIDENT: DO NOT

USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

Satisfaction guaranteed – Or we’ll

replace it or give you your money

back. For questions or comments

please call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

† This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Children’s Tylenol® Chewables.

50844 REV0424E45008

Equate 44-450 REV0424E
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
  • any new symptoms appear
  • redness or swelling is present
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If Your Child Has

liver disease.

Active Ingredient (in Each Chewable Tablet)

Acetaminophen 160 mg

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin.


Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • sore throat
    • flu
    • toothache
    • the common cold
  • temporarily reduces fever
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 give more than directed
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (chewable tablets)*
Under 24 Under 2 Ask a doctor
24-35 2-3 1 tablet
36-47 4-5 1 1/2 tablets
48-59 6-8 2 tablets 
60-71 9-10 2 1/2 tablets
72-95 11 3 tablets 

*or as directed by a doctor

Do Not Use (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.



Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • avoid high humidity
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions Or Comments? (Questions or comments?)

1-888-287-1915

Principal Display Panel (Principal display panel)

equate™

NDC 49035-777-08

Compare to

Children's

Tylenol® Chewables active

ingredient

children's 

PAIN & FEVER

Acetaminophen 160 mg

Chewable Tablets

■  Pain Reliever / Fever Reducer

2-11 YEARS

■ Aspirin Free

■ Ibuprofen Free

Bubblegum Flavor

24 Chewable Tablets

Actual Size

Chew or crush

tablets completely

before swallowing.

TAMPER EVIDENT: DO NOT

USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

Satisfaction guaranteed – Or we’ll

replace it or give you your money

back. For questions or comments

please call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

† This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Children’s Tylenol® Chewables.

50844 REV0424E45008

Equate 44-450 REV0424E
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
  • any new symptoms appear
  • redness or swelling is present
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

liver disease.

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

Acetaminophen 160 mg

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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