ACETAMINOPHEN- acetaminophen tablet, coated 
Rugby Laboratories

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Rugby 44-519

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

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:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

  • new symptoms occur
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • 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.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Questions or comments?

(800) 616-2471

Principal display panel

Rugby®

NDC 0536-1292-29

Compare to the active ingredient in
Extra Strength Tylenol® Rapid Release Gels*

Extra Strength
Acetaminophen
500 mg

Pain Reliever / Fever Reducer

Does not contain any Aspirin

Actual Size

100 Gelcaps

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

*This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark Extra Strength Tylenol®
Rapid Release Gels.      50844       REV0322A51912

Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268
www.majorpharmaceuticals.com

Rugby 44-519

Rugby 44-519

ACETAMINOPHEN 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1292
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorred, blueScoreno score
ShapeOVALSize19mm
FlavorImprint Code L;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1292-291 in 1 CARTON05/13/2020
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01305/13/2020
Labeler - Rugby Laboratories (079246066)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464manufacture(0536-1292) , pack(0536-1292)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(0536-1292)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(0536-1292)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(0536-1292)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(0536-1292)

Revised: 8/2023
Document Id: 51b67650-0093-4088-aa8d-073bc87cc55d
Set id: 632198fe-82d6-4353-9e73-ede6d43eba7d
Version: 7
Effective Time: 20230804
 
Rugby Laboratories