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 Ingredients

Acetaminophen 325 mg

Purposes

Pain reliever/fever reducer

Uses

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

Temporarily reduces fever.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

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 the 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

  • Pain gets worse or lasts more than 10 days in adults and children
  • Pain gets worse or lasts more than 5 days in children under 12 years
  • 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 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
AGEDOSE
Adults and children 12 years and over
  • Take 2 tablets every 4 to 6 hours while symptoms last
  • Do not take more than 12 tablets in 24 hours
Children 6 to 11 years
  • Take 1 tablet every 4 to 6 hours while symptoms last
  •  Do not take more than 5 tablets in 24 hours
Children under 6 yearsDo not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

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 325 mg

ONDRA Pharmaceuticals
See new warning information and directions

Regular Strength

Acetaminophen 325 mg
PAIN RELIEVER
FEVER REDUCER
CONTAINS NO ASPIRIN

Compare to active ingredient in Regular strength Tylenol®
1000 tablets
325mg each


ONDRA Pharmaceuticals
See new warning information and directions

Regular Strength

Acetaminophen 325 mg
PAIN RELIEVER
FEVER REDUCER
CONTAINS NO ASPIRIN

Compare to active ingredient in Regular strength Tylenol®

100 tablets
325mg each
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ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51645-600
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 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:51645-600-01100 TABLET ( TABLET) in 1 BOTTLE, PLASTICNone
2NDC:51645-600-101000 TABLET ( TABLET) in 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34304/04/2012

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