ACETAMINOPHEN  - acetaminophen tablet 
Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals

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 ingredient (in each tablet)

Acetaminophen 500 mg

Purposes

Pain reliever/fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen.The maximum daily dose of this product is 6 tablets (3,000 mg) 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 occur
  • 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). Quick 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

Inactive ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Questions?

If you have any questions or comments, or to report an adverse event, please contact 1 800-medline.

Principal Display Panel

ONDRA
PHARMACEUTICALS
See New Warnings Information and Directions

Extra Strength

Acetaminophen 500 mg
PAIN RELIEVER
FEVER REDUCER
CONTAINS NO ASPIRIN

Compare to the Active Ingredient in Extra Strength Tylenol®

This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark of Extra Strength Tylenol®

1000 TABLETS 500 mg each
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ONDRA
PHARMACEUTICALS
See New Warnings Information and Directions

Extra Strength

Acetaminophen 500 mg
PAIN RELIEVER
FEVER REDUCER
CONTAINS NO ASPIRIN

Compare to the Active Ingredient in Extra Strength Tylenol®

This product is not manufactured or distributed by McNeil Consumer Healthcare owner of the registered trademark of Extra Strength Tylenol®

100 TABLETS 500 mg each
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ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51645-602
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:51645-602-01100 TABLET ( TABLET) in 1 BOTTLE, PLASTICNone
2NDC:51645-602-101000 TABLET ( TABLET) in 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34303/30/2012

Labeler - Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals (055942270)
Registrant - Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals (055942270)
Establishment
NameAddressID/FEIOperations
Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals055942270manufacture

Revised: 04/2012 Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals