Best Choice 44-449-children

Best Choice 44-449-children
SPL v13
SPL
SPL Set ID 1d3584e3-f128-4441-b842-aba45053ea53
Route
ORAL
Published
Effective Date 2026-03-11
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 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 2005-01-28

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
  • 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 15°-30°C (59°-86°F)
  • 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?

1-800-426-9391

Principal Display Panel

Compare to the active ingredient in

Children’s Tylenol®**

Best

Choice®

Children's

Pain Reliever

Acetaminophen 160 mg

Chewable Tablets

Pain Reliever/Fever Reducer



For ages 2 to 11 years

Ibuprofen Free • Aspirin Free

24 Chewable Tablets

Do not swallow tablets whole.

Actual Size

Grape Flavor

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

**This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the

registered trademark Children’s Tylenol®.

50844     REV0522B44908

PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO.

5000 KANSAS AVE, KANSAS CITY, KS 66106

Best Choice®

100% Guaranteed

www.bestchoicebrand.com

Scan here for more

product information.


Call 1-844-292-1112 for

more product information.

Best Choice 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)
  • 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 15°-30°C (59°-86°F)
  • 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?)

1-800-426-9391

Principal Display Panel

Compare to the active ingredient in

Children’s Tylenol®**

Best

Choice®

Children's

Pain Reliever

Acetaminophen 160 mg

Chewable Tablets

Pain Reliever/Fever Reducer



For ages 2 to 11 years

Ibuprofen Free • Aspirin Free

24 Chewable Tablets

Do not swallow tablets whole.

Actual Size

Grape Flavor

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

**This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the

registered trademark Children’s Tylenol®.

50844     REV0522B44908

PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO.

5000 KANSAS AVE, KANSAS CITY, KS 66106

Best Choice®

100% Guaranteed

www.bestchoicebrand.com

Scan here for more

product information.


Call 1-844-292-1112 for

more product information.

Best Choice 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

All Sections (JSON)