CLEAR CHOICE EXTRA STRENGTH PAIN RELIEVER- acetaminophen tablet

Clear Choice Extra Strength Pain Reliever by

Drug Labeling and Warnings

Clear Choice Extra Strength Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Athlete's Needs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CLEAR CHOICE EXTRA STRENGTH PAIN RELIEVER 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53185-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	WHITE (micro-filmed coated white)	Score	no score
Shape	ROUND (round, standard convex)	Size	12mm
Flavor		Imprint Code	AZ235
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53185-002-00	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/13/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	09/13/2012

Labeler - Athlete's Needs, Inc. (619703945)