Active Ingredient
Acetaminophen 500 mg
Pain Reliever Chewable Gel
FDA Label NDC 59726-113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by P & L Development, Llc for the product Pain Reliever (NDC 59726-113). 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, ask a doctor or pharmacist before use if, 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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Do Not Use
- 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
liver disease
Ask A Doctor Or Pharmacist Before Use If
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.
Pregnancy/Breastfeeding
ask a health profession before use.
Keep Out Of Reach Of Children
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
- 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
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
Acetaminophen 500 mg Cherry Flavor
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