ACETAMINOPHEN- acetaminophen tablet 
Major Pharmaceuticals

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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 in a dry place at 15° – 30°C (59° – 86°F).

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

Call 1-800-231-4670

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by:

MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268

*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol®.

MAJOR

THIS LARGE SIZE PACKAGE FOR DISPENSING PURPOSE ONLY

See New Warnings Information and Directions

Acetaminophen Extra Strength Tablets

Aspirin Free

Extra Strenght Pain reliever

Compare to active ingredient in Extra Strength Tylenol®* Tablets

1000 tablets

500mg each

Major Label

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:0904-6730-60100 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
2NDC:0904-6730-801000 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
3NDC:0904-6730-591 in 1 CARTON09/12/2018
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0904-6730-6110 in 1 BOX, UNIT-DOSE09/12/2018
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01309/12/2018
Labeler - Major Pharmaceuticals (191427277)

Revised: 5/2024
Document Id: 17f3b749-01e8-2561-e063-6294a90a5d3b
Set id: 76cb8209-6c43-322e-e053-2991aa0a51eb
Version: 3
Effective Time: 20240508
 
Major Pharmaceuticals