Foster And Thrive 44-079

Foster And Thrive 44-079
SPL v2
SPL
SPL Set ID 4dda3534-4e83-447b-be75-33dadce06c47
Route
ORAL
Published
Effective Date 2025-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-27

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

    • toothache

    • sore throat

    • flu

    • 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

  • shake well before using
  • mL = milliliter
  • only use the dose cup provided
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (mL)*
Under 24

Under 2 Ask a doctor
24-35 2-3 5 mL
36-47 4-5 7.5 mL
48-59 6-8 10 mL
60-71 9-10 12.5 mL
72-95 11 15 mL

*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
  • 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

anhydrous citric acid, FD&C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-800-426-9391

Principal Display Panel

NDC 70677-1286-1

†COMPARE TO THE ACTIVE INGREDIENT IN

CHILDREN’S TYLENOL® ORAL SUSPENSION

Foster & Thrive™

Children’s

Pain & Fever

Acetaminophen

160 mg per 5 mL

Oral Suspension

PAIN RELIEVER/FEVER REDUCER

Pain & Fever

Ages 2-11 Years

Alcohol Free

Ibuprofen Free

16 FL OZ (473 mL)

DOSING CUP

INCLUDED

STRAWBERRY FLAVOR

TAMPER EVIDENT: DO NOT USE IF PRINTED

WRAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark Children’s

Tylenol® Oral Suspension.      50844    ORG042407921

©2023 McKesson Corporation

Distributed by: McKesson Corp., via Strategic Sourcing Services LLC.,

Memphis, TN 38141 Money Back Guarantee www.fosterandthrive.com

Foster & Thrive 44-079
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 5 Ml)

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

    • toothache

    • sore throat

    • flu

    • 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

  • shake well before using
  • mL = milliliter
  • only use the dose cup provided
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (mL)*
Under 24

Under 2 Ask a doctor
24-35 2-3 5 mL
36-47 4-5 7.5 mL
48-59 6-8 10 mL
60-71 9-10 12.5 mL
72-95 11 15 mL

*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)
  • 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)

anhydrous citric acid, FD&C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

NDC 70677-1286-1

†COMPARE TO THE ACTIVE INGREDIENT IN

CHILDREN’S TYLENOL® ORAL SUSPENSION

Foster & Thrive™

Children’s

Pain & Fever

Acetaminophen

160 mg per 5 mL

Oral Suspension

PAIN RELIEVER/FEVER REDUCER

Pain & Fever

Ages 2-11 Years

Alcohol Free

Ibuprofen Free

16 FL OZ (473 mL)

DOSING CUP

INCLUDED

STRAWBERRY FLAVOR

TAMPER EVIDENT: DO NOT USE IF PRINTED

WRAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark Children’s

Tylenol® Oral Suspension.      50844    ORG042407921

©2023 McKesson Corporation

Distributed by: McKesson Corp., via Strategic Sourcing Services LLC.,

Memphis, TN 38141 Money Back Guarantee www.fosterandthrive.com

Foster & Thrive 44-079
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 5 Ml) (Active ingredient (in each 5 mL))

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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