DrugCite

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

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purposes

Pain reliever/fever reducer

Uses

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

  • Headache
  • Muscular aches
  • Backache
  • Minor pain of arthritis
  • The common cold
  • Toothache
  • Premenstrual and menstrual cramps
Temporarily reduces fever.

Warnings

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

  • adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen 
  • adult has 3 or more alcoholic drinks every day while using this product

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
AGE DOSE
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 years Do 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


  • Do not use if imprinted safety seal under cap is broken or missing
  • Store at room temperature

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

Regular Strength

Acetaminophen
325 mg

PAIN RELIEVER  FEVER REDUCER
CONTAINS NO ASPIRIN

Compare to the Active Ingredient in Regular Strength Tylenol®

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

1000 TABLETS  325 mg each
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ONDRA PHARMACEUTICALS


Regular Strength

Acetaminophen
325 mg

PAIN RELIEVER  FEVER REDUCER
CONTAINS NO ASPIRIN

Compare to the Active Ingredient in Regular Strength Tylenol®

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

100 TABLETS 325 mg each
front.jpg

ACETAMINOPHEN 
acetaminophen  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 51645-600
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE  
STARCH, CORN  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
STEARIC ACID  
Product Characteristics
Color white Score 2 pieces
Shape ROUND (round flat faced beveled edge) Size 12mm
Flavor Imprint Code GPI;A325
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 51645-600-01 100 TABLET In 1 BOTTLE, PLASTIC None
2 51645-600-10 1000 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 03/30/2012

Labeler - Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals (055942270)
Registrant - Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals (055942270)
Establishment
Name Address ID/FEI Operations
Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals 055942270 manufacture
Revised: 04/2012Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals