Kroger 44-449

Kroger 44-449
SPL v7
SPL
SPL Set ID 2d422b0d-da15-4906-9daa-1e275818420c
Route
ORAL
Published
Effective Date 2025-02-15
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 Dextrose Monohydrate Ethylcellulose, Unspecified Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Mannitol High Density Polyethylene Stearic Acid Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: 44;449 Shape: round Color: purple Size: 16 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-18

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
  • do not give for more than 5 days unless directed by a doctor
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
  • 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
Other Information
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid high humidity
  • 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, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions Or Comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of

CHILDREN’S TYLENOL® CHEWABLES †See bottom panel

Chew or crush

tablets completely

before swallowing.

NDC 30142-449-08

Kroger®

Ages 2-11

children's

Pain Relief

Acetaminophen 160 mg

Chewable Tablets

Pain Reliever/Fever Reducer

Ibuprofen Free/Aspirin Free

actual size

Grape Flavored

24 CHEWABLE TABLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†Children's Tylenol® Chewables is a registered trademark

of Johnson & Johnson Corporation, New Brunswick New

Jersey 08933. Johnson & Johnson Corporation is not

affiliated with The Kroger Co. or this product.

50844         REV0522A44908

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

For More Product Information,

Scan UPC Using Your Kroger App or

Call 800-632-6900

Our Brands. Our Guarantee.

Love It or Your Money Back.

www.kroger.com

Kroger 44-449
When Using This Product

do not exceed recommended dosage.

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.

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
  • do not give for more than 5 days unless directed by a doctor
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.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product
Other Information (Other information)
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid high humidity
  • 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, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions Or Comments? (Questions or comments?)

1-800-632-6900

Principal Display Panel (Principal display panel)

COMPARE TO the active ingredient of

CHILDREN’S TYLENOL® CHEWABLES †See bottom panel

Chew or crush

tablets completely

before swallowing.

NDC 30142-449-08

Kroger®

Ages 2-11

children's

Pain Relief

Acetaminophen 160 mg

Chewable Tablets

Pain Reliever/Fever Reducer

Ibuprofen Free/Aspirin Free

actual size

Grape Flavored

24 CHEWABLE TABLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†Children's Tylenol® Chewables is a registered trademark

of Johnson & Johnson Corporation, New Brunswick New

Jersey 08933. Johnson & Johnson Corporation is not

affiliated with The Kroger Co. or this product.

50844         REV0522A44908

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

For More Product Information,

Scan UPC Using Your Kroger App or

Call 800-632-6900

Our Brands. Our Guarantee.

Love It or Your Money Back.

www.kroger.com

Kroger 44-449
When Using This Product (When using this product)

do not exceed recommended dosage.

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.

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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