Heb 44-449

Heb 44-449
SPL v6
SPL
SPL Set ID c713556c-cb9e-4ed2-bc2f-49b3d6256c0f
Route
ORAL
Published
Effective Date 2025-04-21
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 2022-02-09

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

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 25°C (77°F); 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 Children’s Tylenol® Chewables

active ingredient†

NDC 37808-499-08

H-E-B®

Children's

Pain Reliever

Acetaminophen
160 mg

Chewable Tablets

Pain Reliever/Fever Reducer

For ages 2 to 11

• Relieves Pain + Fever

• Ibuprofen Free

• Aspirin Free

Grape

Flavor

24 CHEWABLE

TABLETS

actual size

Chew or crush tablets

completely before swallowing.

Do not swallow tablets whole.

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 Kenvue Inc., owner of the registered trademark

Children’s Tylenol®.

50844        REV0424C44908

MADE WITH

PRIDE & CARE FOR H-E-B®

SAN ANTONIO, TX 78204

HEB 44-449

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.

Active Ingredient (in Each Chewable Tablet)

Acetaminophen 160 mg

Ask A Doctor Before Use If Your Child Has 

liver disease.

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)

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 25°C (77°F); 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 (Principal display panel)

Compare to Children’s Tylenol® Chewables

active ingredient†

NDC 37808-499-08

H-E-B®

Children's

Pain Reliever

Acetaminophen
160 mg

Chewable Tablets

Pain Reliever/Fever Reducer

For ages 2 to 11

• Relieves Pain + Fever

• Ibuprofen Free

• Aspirin Free

Grape

Flavor

24 CHEWABLE

TABLETS

actual size

Chew or crush tablets

completely before swallowing.

Do not swallow tablets whole.

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 Kenvue Inc., owner of the registered trademark

Children’s Tylenol®.

50844        REV0424C44908

MADE WITH

PRIDE & CARE FOR H-E-B®

SAN ANTONIO, TX 78204

HEB 44-449

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.

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

Acetaminophen 160 mg

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

liver disease.

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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