Foster And Thrive 44-450

Foster And Thrive 44-450
SPL v5
SPL
SPL Set ID af2cbbaf-9b73-440a-bc88-a790cafccc6b
Route
ORAL
Published
Effective Date 2025-11-07
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 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 2023-04-26

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

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?

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel

NDC 70677-1127-1

Foster & Thrive™

COMPARE TO

CHILDREN’S TYLENOL® CHEWABLES

ACTIVE INGREDIENT**

Children’s Chewables

Acetaminophen 160 mg

Chewable Tablets

PAIN RELIEVER/FEVER REDUCER

Ibuprofen Free

Ages 2-11

Aspirin Free

Bubble Gum Flavored

ACTUAL SIZE

24 CHEWABLE TABLETS

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

Kenvue Inc., owner of the registered trademark

Children’s Tylenol® Chewables. 50844 REV0424A45008

Rev. 01/25

©2023 McKesson Corporation

Distributed by:

McKesson Corp., via SSSL., Memphis, TN 38141

Money Back Guarantee www.fosterandthrive.com

Foster and thrive 44-450
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)
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • see end flap for expiration date and lot number
  • avoid high humidity

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?)

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel (Principal display panel)

NDC 70677-1127-1

Foster & Thrive™

COMPARE TO

CHILDREN’S TYLENOL® CHEWABLES

ACTIVE INGREDIENT**

Children’s Chewables

Acetaminophen 160 mg

Chewable Tablets

PAIN RELIEVER/FEVER REDUCER

Ibuprofen Free

Ages 2-11

Aspirin Free

Bubble Gum Flavored

ACTUAL SIZE

24 CHEWABLE TABLETS

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

Kenvue Inc., owner of the registered trademark

Children’s Tylenol® Chewables. 50844 REV0424A45008

Rev. 01/25

©2023 McKesson Corporation

Distributed by:

McKesson Corp., via SSSL., Memphis, TN 38141

Money Back Guarantee www.fosterandthrive.com

Foster and thrive 44-450
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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