FDA.reportPublic FDA data

Children’s Pain and Fever Chewables Acetaminophen

Manufacturer
MEIJER DISTRIBUTION INC
Effective date
2026-10-01
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-10-03 00:01:34

Label at a glance#

ProductMeijer Childrens Pain and Fever Reducer
Active ingredientACETAMINOPHEN
Label structure8 sections

Indications and uses

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

Dosage and administration

• this product does not contain directions or complete warnings for adult use. • do not give more than directed (see overdose warning) • find the right dose on chart below. If possible, use weight to dose; otherwise use age. • chew completely do not swallow whole • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours Weight (lbs) under 24 24-35 36-47 48-59 60-71 72-95 Age (yr) ...

Storage and handling

• store at room temperature. Avoid high humidity. Protect from light. • see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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 reaction. Symptom may include:

  • skin reddening
  • blister
  • rash
  • If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if your child has

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • find the right dose on chart below. If possible, use weight to dose; otherwise use age.
  • chew completely do not swallow whole
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours

Weight (lbs)

under 24

24-35

36-47

48-59

60-71

72-95

Age (yr)

under 2 years

2-3 years

 4-5 years

6-8 years

9-10 years

11 years

Dose (tablets)*

 ask a doctor

1 tablet

1 ½ tablets

2 tablets

2 ½ tablets

3 tablets

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature. Avoid high humidity. Protect from light.
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, crospovidone, D&C Red No. 30, dextrose, flavor, hydroxypropylcellulose, magnesium stearate, maltodextrin, silicon dioxide, sodium carboxymethylcellulose, starch, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41250-246-24

Compare to active ingredient in Children’s Tylenol® Chewables*

Children’s

Pain + Fever Chewables

Acetaminophen 160 mg each

Pain reliever/Fever reducer

Aspirin free

Ibuprofen free

AGES 2-11

Bubblegum Flavor

Naturally and Artificially Flavored

24 Chewable Tablets – 160 mg each

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 McNeil Consumer Healthcare, owner of the registered trademark Children’s Tylenol® Chewables.

IMPORTANT: Keep this carton for future reference on full labeling.

Distributed by:

MEIJER DISTRIBUTION INC

GRAND RAPIDS, MI, 49544

www.meijer.com

Children's Pain and Fever Chewables Acetaminophen
Children's Pain and Fever Chewables Acetaminophen

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130719283723819GTIN-13: 0719283723819
EAN-13: 0719283723819
GTIN-12: 719283723819
UPC-A: 719283723819
GTIN storage (14 digits): 00719283723819		160GR24PVFC.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41250-24641250-246-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
D&C RED NO. 302S42T2808BIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-10-24full-release2026-06-01 01:40:30
82024-10-18full-release2026-06-01 00:27:12

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
41e61014-cd65-22b5-e063-6394a90a1c48b416857a-22d5-4504-9bbc-69ab5429654d2025-10-24WarningsExact identifier
spl set id: b416857a-22d5-4504-9bbc-69ab5429654d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.