Active Ingredient (In Each Tablet)
Acetaminophen 500 mg
Clear Choice Extra Strength Pain Reliever
FDA Label NDC 53185-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Athlete's Needs, Inc. for the product Clear Choice Extra Strength Pain Reliever (NDC 53185-002). 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 (in each tablet), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you, 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
Purposes
Pain reliever/fever reducer
Uses
temporary relief of minor aches and pains associated with
- common cold
- headache
- toothache
- muscular aches
- backache
- minor pain of arthritis
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen.
- Severe liver damage may occur if
- adult takes more than 4,000mg of acetaminophen in 24 hours
- taken with other drugs containing acetaminophen
- adult has 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
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription).
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask A Doctor Before Use If You Have
liver disease
Ask A Doctor Or Pharmacist Before Use If You
are taking blood thinning drug warfarin
Stop Use And Ask A Doctor If
- symptoms do not improve
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- new symptoms occur
- redness or swelling is present
- a rare sensitivity reaction occurs
- You may report side effects to 800-326-8147
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.
Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Do not exceed recommended dosage.
Directions
do not use more than directed (see overdose warning)
Do not use more than 10 days unless directed by a doctor
- adults and children 12 years and over: take two tablets every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.
- children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
Other Information
- store between 59°-86°C (15°-30°F)
- do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients
corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
Package Label
Clear Choice
Extra Strength
PAIN RELIEVER
ACETAMINOPHEN
PAIN & FEVER RELIEF
CONTAINS NO ASPIRIN
CAFFEINE FREE
Compare to Extra Strength Tylenol (R)
See new warnings information
100 Tablets
500 mg Each
Questions? Contact A.N.I. Toledo OH
Manufactured for A.N.I. Toledo OH 436253
Acetaminophen 500mg (Pain Reliever Acetaminophen 500mg 1)
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