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Clear Choice Extra Strength Pain Reliever

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

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

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
  • 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 59º-86ºC (15º-30ºF)
  • 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




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 GLYCOL, UNSPECIFIED 
STEARIC ACID 
TITANIUM DIOXIDE 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
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.

Medically reviewed on Dec 11, 2018

Further information

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

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