FDA.reportPublic FDA data

acetaminophen 500 mg cherry chewable gel

Manufacturer
P & L Development, LLC
Effective date
2026-06-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
weekly-update
Hydrated at
2026-07-17 21:41:55

Label at a glance#

ProductPain Reliever
Active ingredientACETAMINOPHEN
Label structure7 sections

Indications and uses

temporarily relieves minor aches and pains due to headache  the common cold  backache minor pain of arthritis  toothache  muscular aches  premenstrual and menstrual cramps temporarily reduces fever

Dosage and administration

do not take more than directed (see Overdose warning)  adults and children 12 years and chew 2 chewable gels every 6 hours while symptoms last  do not take more than 6 chewable gels in 24 hours, unless directed by a doctor  do not take for more than 10 days unless directed by a doctor children under 12 years: do not use

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg 

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to
  • headache 
  • the common cold 
  • backache
  • minor pain of arthritis 
  • toothache 
  • muscular aches 
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen.Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin 

When using this product

OTC - WHEN USING SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain gets worse or lasts more than 10 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.

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health profession before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any sign or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see Overdose warning) 
  • adults and children 12 years and
  • chew 2 chewable gels every 6 hours while symptoms last 
  • do not take more than 6 chewable gels in 24 hours, unless directed by a doctor 
  • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: do not use

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Tylenol Extra Strength 

Adult Extra Strength 

Pain Reliever 

Acetaminophen 500 mg 

Pain reliever/Fever reducer

Aspirin-free 

ibuprofen-free

For ages 12 years and over

50 Solid chewable gels 

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen 500 mg Cherry Flavor
Acetaminophen 500 mg Cherry Flavor

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130000000000000GTIN-13: 0000000000000
EAN-13: 0000000000000
GTIN-12: 000000000000
UPC-A: 000000000000
GTIN storage (14 digits): 00000000000000		acetaminophen-500-mg-cherry-chewable-gel-1.jpg

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59726-11359726-113-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
ALCOHOL3K9958V90MIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CORN SYRUP9G5L16BK6NIACT

Source Document#

Source XML

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
Pain RelieverACETAMINOPHENP & L Development, LLCfc841cba-8f4f-407b-97de-0422977515bd2026-06-30WarningsExact identifier
ndc (package): 59726-113-05
ndc (product): 59726-113
ndc11 (package): 59726011305
spl id: f2ee0f64-faae-46cd-ba8e-724022197d91
spl set id: fc841cba-8f4f-407b-97de-0422977515bd

Reported adverse events (FAERS/openFDA)#

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