MedPath

Childrens Pain and Fever

Foster and Thrive 44-079

Approved
Approval ID

4dda3534-4e83-447b-be75-33dadce06c47

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

Strategic Sourcing Services LLC

DUNS: 116956644

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetaminophen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70677-1286
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (12)

ACETAMINOPHENActive
Quantity: 160 mg in 5 mL
Code: 362O9ITL9D
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6S
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/27/2025

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](/dailymed/image.cfm?name=foster-and- thrive-44-079-1.jpg&id=877097)

Foster & Thrive 44-079

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/27/2025

Uses

  • temporarily relieves minor aches and pains due to:

    • headache

    • toothache

    • sore throat

    • flu

    • the common cold

  • temporarily reduces fever

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/27/2025

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/27/2025

Purpose

Pain reliever/fever reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 5/27/2025

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.

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.

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.

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/27/2025

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/27/2025

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 5/27/2025

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/27/2025

Questions or comments?

1-800-426-9391

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Childrens Pain and Fever - FDA Drug Approval Details