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Clear Choice Extra Strength Pain Reliever

Medically reviewed on August 24, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Athlete's Needs Inc
NDC Code: 53185-002

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Clear Choice Extra Strength Pain Reliever

Active Ingredient (in each tablet)

Acetaminophen 500 mg

Purposes

Analgesic/Antipyretic

Uses

temporary relief of minor aches and pains associated with

  • common cold
  • headache
  • toothache
  • muscular aches
  • backache
  • arthritis
  • menstrual cramps
  • and reduction of fever

Warnings

Liver warning

This product contains acetaminophen, Severe liver damage may occur if you take

  • more than 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks ever day while using this product

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 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 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 (1,000 mg) every 6 hours while symptoms last. Do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor.

Children under 12 years of age

Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other information

store at room temperature

do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

corn starch, hydroxypropyl methylcellulose, polyethylene glycol, stearic acid, titanium dioxide.

May contain povidone, pregelatinized starch and sodium starch glycolates.

This product not manufactured or distributed by McNeil-Consumer Healthcare Co., owner of the trademark Tylenol(R).

Package Label

Clear Choice

Extra Strength

PAIN RELIEVER

ACETAMINOPHEN

PAIN AND 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





CLEAR CHOICE EXTRA STRENGTH PAIN RELIEVER 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53185-002
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
Colorwhite (micro-filmed coated white) Scoreno score
ShapeROUND (round, standard convex) Size12mm
FlavorImprint CodeAZ235
Contains    
Packaging
#Item CodePackage Description
1NDC:53185-002-00100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/13/2012
Labeler - Athlete's Needs Inc (619703945)

 
Athlete's Needs Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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