RUGBY REGULAR STRENGTH ACETAMINOPHEN- acetaminophen tablet 
RUGBY LABORATORIES

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Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

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: • skin reddening • blisters • rash

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 the user has

liver disease

Ask a doctor or pharmacist before use if the user is

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 the reach of children.

Overdose warning:

In the 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 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directe by a doctor
  • do not use for more than 10 days unless directed by a doctor
children 6 to under 12 years
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 yearsask a doctor

Other information

Inactive ingredients

povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions or comments?

(866) 572-2756 (Mon-Fri 8 AM to 4 PM EST)

Rugby®

NDC 0536-1327-10

*Compare to the active ingredients in Tylenol® Regular Strength*

Regular Strength

Acetaminophen

325 mg 

Pain Reliever/

Fever Reducer

1000 Tablets

Rugby Regular Strength Acetaminophen Tablet

RUGBY REGULAR STRENGTH ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1327
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code PH020
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1327-0650 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/11/2021
2NDC:0536-1327-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/11/2021
3NDC:0536-1327-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/11/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01303/11/2021
Labeler - RUGBY LABORATORIES (079246066)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835analysis(0536-1327) , manufacture(0536-1327) , pack(0536-1327) , label(0536-1327)

Revised: 12/2024
Document Id: 12233e8a-799d-40a8-a08c-4059ee360fa6
Set id: 295b0d00-4d4a-405f-9325-d01c5d4f3ed4
Version: 3
Effective Time: 20241220
 
RUGBY LABORATORIES