ACETAMINOPHEN- acetaminophen tablet 
PD-Rx Pharmaceuticals, Inc.

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Acetaminophen

Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/ Fever reducer

Uses

Temporarily reduces fever and relieves minor aches and pains due to:

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: skin reddening ,blisters, rash. If a skin reaction occurs, stop use and seek medical help right away.

  • 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 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: 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 tablets every 6 hours while symptoms last

• do not take more than 6 tablets in 24 hours, unless directed by a doctor

• do not take for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

Other Information

store at room temperature

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

Call (800) 616-2471

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

16 HOW SUPPLIED/STORAGE AND HANDLING

Acetaminophen tablets, 500 mg are supplied as white, scored round tablets, debossed with “54;27”.

In bottles of 20: (NDC 72789-241-20)

In bottles of 30: (NDC 72789-241-30)

In bottles of 50: (NDC 72789-241-50)

In bottles of 60: (NDC 72789-241-60)

In bottles of 100: (NDC 72789-241-01)

Acetaminophen Extra Strength Tablets

Extra Strenght Pain reliever

500mg each

72789241 Label

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72789-241(NDC:0904-6730)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize12mm
FlavorImprint Code 54;27
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72789-241-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2022
2NDC:72789-241-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2022
3NDC:72789-241-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2022
4NDC:72789-241-5050 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/12/2022
5NDC:72789-241-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01309/12/2018
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(72789-241)

Revised: 10/2023
Document Id: 06c1a044-cb6e-be06-e063-6294a90a6687
Set id: 3f96aeb1-a533-4d36-9a1f-62fc094b6754
Version: 6
Effective Time: 20231002
 
PD-Rx Pharmaceuticals, Inc.