ACETAMINOPHEN- acetaminophen tablet 
St. Mary's Medical Park Pharmacy

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Major Pharmaceuticals Acetaminophen Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

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: 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

adults and children 12 years and over

  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor

children under 12 years

ask a doctor

Other information

Inactive ingredients

carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain one or more of these ingredients

Questions or comments?

1-800-616-2471

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ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60760-534(NDC:0904-6720)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize16mm
FlavorImprint Code L484
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60760-534-4040 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/07/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01309/07/2021
Labeler - St. Mary's Medical Park Pharmacy (063050751)
Establishment
NameAddressID/FEIBusiness Operations
St Mary's Medical Park Pharmacy063050751relabel(60760-534) , repack(60760-534)

Revised: 12/2023
Document Id: 0ccb65a9-784e-bce6-e063-6394a90a51c0
Set id: cb6bc40b-0b9a-e8f6-e053-2a95a90a797a
Version: 2
Effective Time: 20231218
 
St. Mary's Medical Park Pharmacy