CLEAR CHOICE REGULAR STRENGTH PAIN RELIEVER- acetaminophen tablet

Clear Choice Regular Strength Pain Reliever by

Drug Labeling and Warnings

Clear Choice Regular 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 325 mg

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

Allergy alert: Acetaminophen may cause sever 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

• 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 59º-86ºF (15º-30ºC)
• 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.

INGREDIENTS AND APPEARANCE

CLEAR CHOICE REGULAR STRENGTH PAIN RELIEVER 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53185-005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 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	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	AZ234
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53185-005-00	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/03/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	06/03/2013

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