ACETAMINOPHEN- acetaminophen tablet 
A-S Medication Solutions

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5427-Major

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

SAVE CARTON FOR COMPLETE DRUG FACTS

Do not use if carton is open or if imprinted safety seal under cap is broken or missing.

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

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

HOW SUPPLIED

Product: 50090-5313

NDC: 50090-5313-1 30 TABLET in a BOTTLE

NDC: 50090-5313-2 100 TABLET in a BOTTLE

NDC: 50090-5313-3 50 TABLET in a BOTTLE

NDC: 50090-5313-4 24 TABLET in a BOTTLE

NDC: 50090-5313-5 20 TABLET in a BOTTLE

Acetaminophen

Label Image
ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-5313(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:50090-5313-130 in 1 BOTTLE; Type 0: Not a Combination Product10/29/2020
2NDC:50090-5313-2100 in 1 BOTTLE; Type 0: Not a Combination Product10/29/2020
3NDC:50090-5313-350 in 1 BOTTLE; Type 0: Not a Combination Product10/29/2020
4NDC:50090-5313-424 in 1 BOTTLE; Type 0: Not a Combination Product10/29/2020
5NDC:50090-5313-520 in 1 BOTTLE; Type 0: Not a Combination Product10/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01309/12/2018
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-5313) , REPACK(50090-5313)

Revised: 12/2023
Document Id: 7179bb36-c5cd-4c47-9f5c-f8a19f41ced0
Set id: 061c91d5-5aa8-4556-a344-197b7e8a10b8
Version: 7
Effective Time: 20231216
 
A-S Medication Solutions