ACETAMINOPHEN- acetaminophen extra strength tablet 
Akron Pharma 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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Acetaminophen 500 mg
Extra Strength

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

To reduce fever and 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 

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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if the user has ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if the user has

  • has liver disease
  • is a child with pain of arthritis

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Stop use and ask a doctor if:

  • pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
  • 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 (see overdose warning)

 adults & children 12 years and over
  •  take 2 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
 child under 12 years ask a doctor

Other information

Inactive Ingredients:

pregelatinized starch, microcrystalline cellulose, povidone (PVP K-30), colloidal silicon dioxide, croscarmellose sodium, stearic acid.

Questions or Comments?

Call toll-free 1-877-225-6999

Manufactured for
Akron Pharma, Inc.,

373 RT US46 W Building E,

Suite 117, Fairfeld, NJ - 07004

* This product is not manufactured or distributed by McNeal Consumer Healthcare, Owner of registered trademark Tylenol.

500mg-100ct

ACETAMINOPHEN 
acetaminophen extra strength tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-8027
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize12mm
FlavorImprint Code APAP500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71399-8027-1100 in 1 BOTTLE; Type 0: Not a Combination Product07/05/2021
2NDC:71399-8027-21000 in 1 BOTTLE; Type 0: Not a Combination Product07/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/05/2021
Labeler - Akron Pharma Inc. (067878881)

Revised: 7/2021
Document Id: b1bf8ea6-c717-4ff7-b2b3-b1265ce6cff5
Set id: 4631df61-00a7-4ea8-849b-7b28ea36e41b
Version: 1
Effective Time: 20210705
 
Akron Pharma Inc.