Active Ingredient (In Each Tablet)
Acetaminophen 325 mg
Clear Choice Regular Strength Pain Reliever Tablet
FDA Label NDC 53185-005
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 Regular Strength Pain Reliever (NDC 53185-005). 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, 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
Purposes
Pain reliever / fever reducer
Uses
temporary relief of minor aches and pains associated with
- the 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 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks ever day while using this product
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause sever skin reactions. symptoms may include:
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.
Ask A Doctor Before Use If
user has liver disease
Ask A Doctor Or Pharmacist Before Use If
the user is taking the 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
- pain gets worse or lasts more than 5 days in children under 12
- 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 1-888-952-0050
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
Adults and children 12 years of age and older:
Take 2 tablets every 4 to 6 hours as needed.
Do not take more than 10 tablets in 24 hours
Children 6 to 11 years of age: Take 1 tablet every 4 to 6 hours as needed
Do not take more than 5 tablets in 24 hours
Children under 6 years of age:
Do not use this regular strenght product. this will provide more than the recommended dose (overdose) and could cause serious health problems
Other Information
- store at room temperature 59°-86°F (15°-30°C)
- 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
Regular Strength
PAIN RELIEVER
ACETAMINOPHEN
PAIN & FEVER RELIEF
CONTAINS NO ASPIRIN
CAFFEINE FREE
Compare to Regular Strength Tylenol (R)
100 Tablets
325 mg Each
Questions?
Contact A.N.I. 6029 Renaissance Place, Toledo OH 43623
Manufactured for A.N.I.
Label1 (Pain Reliever Acetaminophen 325mg 1)
Label2 (Pain Reliever Acetaminophen 325mg 2)
* Please review the disclaimer below.
