childrens acetaminophen
Winco 44-449-children
4749a843-9c93-4edd-9b5f-a1e32666544e
HUMAN OTC DRUG LABEL
Aug 1, 2025
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
Product Classification
Product Specifications
INGREDIENTS (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves minor aches and pains due to:
- headache
- sore throat
- flu
- toothache
- the common cold
- temporarily reduces fever
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each chewable tablet)
Acetaminophen 160 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
WARNINGS SECTION
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
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
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
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
Questions or comments?
Call1-800-824-1706Monday - Friday 9 am - 4 pm MT