ACETAMINOPHEN  - acetaminophen tablet 
FREDS, INC

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.

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Active Ingredients

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses


For the temporary relief of minor aches and pains due to:

Warnings

Liver warnings: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets(3,000mg) in 24 hours. Severe Liver damage may occur if you take
 

Do not use

  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • If you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms appear
  • redness or swelling is present.These could be signs of a serious condition.

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children. Overdose Warning:

Taking more than the recommended dose(overdose) may cause liver damage.In the case of Overdose.get medical help or contact a poison control center right away(1-800-222-1222).Qucik medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Do Not take more than directed

(see overdose warning)

adults and children 12 years and over:

children under 12 years: ask a doctor.

Other information

store at room temperature

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions?

If you have any questions or comments,Or to report an adverse event, please contact (888) 876-6898

Principal Display Panel

fred's
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Extra Strength
Pain reliever

Acetaminophen
Pain reliever/Fever reducer

fred's
Labs tested

100 tablets 500mg each

Compare To
Extra strength Tylenol®
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ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-100
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUND (round flat faced beveled edge) Size12mm
FlavorImprint Code GPI;A5
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:55315-100-01100 TABLET ( TABLET) in 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34304/05/2012

Labeler - FREDS, INC (005866116)
Registrant - Gemini Pharmaceuticals, Inc. (055942270)
Establishment
NameAddressID/FEIOperations
Gemini Pharmaceuticals, Inc.055942270manufacture

Revised: 04/2012 FREDS, INC