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: 50090-5350

NDC: 50090-5350-0 100 TABLET in a BOTTLE

NDC: 50090-5350-1 42 TABLET in a BOTTLE

Acetaminophen

Label Image
ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-5350(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:50090-5350-0100 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2020
2NDC:50090-5350-142 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2021
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(50090-5350) , REPACK(50090-5350)

Revised: 3/2024
Document Id: da8ffe08-33f1-45fd-bb75-311009948cf4
Set id: c4f0f591-8501-4c6d-bf8e-ca3068ff65b5
Version: 11
Effective Time: 20240327
 
A-S Medication Solutions