MedPath

childrens acetaminophen

Winco 44-449-children

Approved
Approval ID

4749a843-9c93-4edd-9b5f-a1e32666544e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

WinCo Foods, LLC

DUNS: 056098817

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 Code67091-311
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (13)

ACETAMINOPHENActive
Quantity: 160 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
D&C RED NO. 27 ALUMINUM LAKEInactive
Code: ZK64F7XSTX
Classification: IACT
D&C RED NO. 30 ALUMINUM LAKEInactive
Code: GE75M6YV5W
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083G
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HIGH DENSITY POLYETHYLENEInactive
Code: UG00KM4WR7
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2025

Principal Display Panel

†Compare to the active ingredient in Children's Tylenol® Chewables

WinCo®
****FOODS

CHILDREN'S
Acetaminophen

Chewable Tablets

PAIN RELIEVER - FEVER REDUCER

Ibuprofen Free, Aspirin Free

Chew or crush
** tablets**
** completely**
** before**
** swallowing.**
** Do not swallow**
** tablets whole.**

AGES
2-11

24
Tablets

160 mg EACH

Grape Flavored

TAMPER EVIDENT: DO NOT USE IF
** PACKAGE IS OPENED OR IF BLISTER**
** UNIT IS TORN, BROKEN OR SHOWS**
** ANY SIGNS OF TAMPERING**

DISTRIBUTED BY:
****WINCO FOODS, LLC, BOISE, ID 83704

†This product is not manufactured or
distributed by Kenvue Inc., owner of the
registered trademark Children’s Tylenol®
Chewables.

50844 REV0424D44908 WF2212

100% SATISFACTION
****GUARANTEE
****Comments & Questions? 800-824-1706

Winco 44-449

Winco 44-449

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2025

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • sore throat
    • flu
    • toothache
    • the common cold
  • temporarily reduces fever

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2025

Active ingredient (in each chewable tablet)

Acetaminophen 160 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/1/2025

Purpose

Pain reliever/fever reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 8/1/2025

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: 8/1/2025

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/1/2025

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 8/1/2025

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/1/2025

Questions or comments?

Call1-800-824-1706Monday - Friday 9 am - 4 pm MT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

childrens acetaminophen - FDA Drug Approval Details