Active Ingredient
Acetaminophen 500 mg
Pain Reliever Chewable Gel
FDA Label NDC 87780-236
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Orelli Inc. for the product Pain Reliever (NDC 87780-236). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
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
Warnings
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
■ 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
liver disease
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
Stop Use And Ask A Doctor If
■ 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
ask a health professional before use.
Keep Out Of Reach Of Children
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
■ 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
■ each gel contains: sodium 25 mg
■ store at controlled room temperature 20-25°C (68-77°F)
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
Orelli Adult Extra Strength Pain Reliever
* Please review the disclaimer below.
