ACETAMINOPHEN- acetaminophen tablet 
A-S Medication Solutions

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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0220K- Major

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/ Fever reducer

Uses

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

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. 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 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 in adults 
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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. This Unit Dose package is not child

resistant and is Intended for Institutional Use Only.

Directions

Other information

store at room temperature

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions or comments?

(800) 616-2471

Tamper Evident: Do not use if sealed blister units are broken or damaged.

Distributed By: MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

HOW SUPPLIED

Product: 50090-4273

NDC: 50090-4273-0 1 TABLET in a BLISTER PACK / 30 in a BOX, UNIT-DOSE

Acetaminophen

Label Image
ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-4273(NDC:0904-6773)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code CPC;220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-4273-030 in 1 BOX, UNIT-DOSE04/18/2019
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/23/2018
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-4273) , REPACK(50090-4273)

Revised: 2/2023
Document Id: bdcf07a8-fcdd-4147-9dcb-d759069ad674
Set id: f49313be-2567-40de-8ae1-78fb28646b99
Version: 6
Effective Time: 20230206
 
A-S Medication Solutions