Adult Extra Strength Pain Reliever Solid Chewable Gels

Manufacturer
Orelli Inc.
Effective date
2026-06-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-04 03:32:28

Label at a glance#

ProductPain Reliever
Active ingredientACETAMINOPHEN
Label structure8 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 over ■ 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

SPL UNCLASSIFIED 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 you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

SPL UNCLASSIFIED SECTION

liver disease

Ask a doctor or pharmacist before use if you are

SPL UNCLASSIFIED SECTION

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

SPL UNCLASSIFIED 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.

If pregnant or breast-feeding

SPL UNCLASSIFIED SECTION

ask a health professional before use.

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 (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 signs or
symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

■ do not take more than directed (see Overdose warning) ■ adults and children 12 years and
over ■ 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

Other information

SPL UNCLASSIFIED SECTION

■ each gel contains: sodium 25 mg
■ store at controlled room temperature 20-25°C (68-77°F)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Orelli

Adult Extra Strength Pain Reliever

Acetaminophen 500 mg

Pain Reliever Fever Reducer

Cherry Flavor

Aspirin Free, Ibuprofen Free

For Ages 12 Years And Over

Solid Chewable Gels 

†Compare to the active ingredient in Tylenol® Extra Strength

†This product is not manufactured or distributed by Kenvue Brands LLC, distributor of Tylenol® Extra Strength.

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Orelli Adult Extra Strength Pain Reliever
Orelli Adult Extra Strength Pain Reliever

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130359726235518GTIN-13: 0359726235518
EAN-13: 0359726235518
GTIN-12: 359726235518
UPC-A: 359726235518
GTIN storage (14 digits): 00359726235518
adult-extra-strength-pain-reliever-solid-chewable--1.jpg

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87780-23687780-236-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

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 RelieverACETAMINOPHENOrelli Inc.4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d2026-06-22WarningsExact identifier
ndc (package): 87780-236-50
ndc (product): 87780-236
ndc11 (package): 87780023650
spl id: 40bd55d6-ecd7-4357-9bc6-905a8ca6cb94
spl set id: 4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d

Reported adverse events (FAERS/openFDA)#

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