ACETAMINOPHEN- acetaminophen tablet 
Rugby Laboratories

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5427-Rugby

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 caused by

• headache

• muscular aches

• the common cold

• toothache

• backache

• minor pain of arthritis

• premenstrual and menstrual cramps

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4,000 mg of acetaminophen in 24 hours

• with other drugs containing acetaminophen

• 3 or more alcoholic drinks every day while using this product

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 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

do not take more than directed (see overdose warning)

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

*Rugby Laboratories is not affiliated with the owner of the registered trademark Tylenol®.

Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268

Questions or comments?
Call (800) 616-2471
www.majorpharmaceuticals.com

Rugby

COMPARE TO THE ACTIVE INGREDIENT IN EXTRA STRENGTH TYLENOL®*

NDC 0536-1172-01

Extra Strength Acetaminophen

500mg each

Pain Reliever/Fever Reducer

Aspirin Free

100 Tablets

Rugby Label

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1172
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)  
POVIDONE K30 (UNII: U725QWY32X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
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:0536-1172-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/01/201811/30/2025
2NDC:0536-1172-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01310/01/2018
Labeler - Rugby Laboratories (079246066)

Revised: 1/2024
Document Id: 0eaf3569-5e07-f353-e063-6294a90a4150
Set id: 76f10ee2-1d6a-097c-e053-2991aa0af526
Version: 3
Effective Time: 20240111
 
Rugby Laboratories