RUGBY ACETAMINOPHEN- acetaminophen tablet 
Rugby Laboratories

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Rugby Laboratories Acetaminophen Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

•
temporarily relieves minor aches and pains due to:
•
headache
•
muscular aches
•
backache
•
minor pain of arthritis
•
the common cold
•
toothache
•
premenstrual and menstrual cramps
•
temporarily reduces fever

Warnings

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

•
adult takes more than 4,000 mg of acetaminophen in 24 hours
•
child takes more than 5 doses in 24 hours
•
taken with other drugs containing acetaminophen
•
adult has 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 the user has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if the user

•
has liver disease
•
is a child with pain of arthritis

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 (for adults) or 5 days (for children)
•
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 4 to 6 hours while symptoms last
•
do not take more than 10 tablets in 24 hours
•
do not use for more than 10 days unless directed by a doctor

children

6-11 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 years

ask a doctor

Inactive ingredients

croscarmellose sodium*, povidone, pregelatinized starch, stearic acid

*may contain this ingredient

Questions or comments?

1-800-645-2158

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN REGULAR STRENGTH TYLENOL®

REGULAR STRENGTH

Acetaminophen

WITHOUT ASPIRIN

PAIN RELIEVER/FEVER REDUCER

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

100 Acetaminophen

Tablets 325 mg Each

4038T-acetaminophen.jpg
RUGBY ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1164
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (beveled edge) Size10mm
FlavorImprint Code 325MG;L403
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1164-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/16/201903/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01301/16/201903/31/2024
Labeler - Rugby Laboratories (079246066)

Revised: 10/2024
Document Id: 7a1a8789-8484-4d5d-84ac-32379d08ecd4
Set id: 7d71d000-d68f-41e0-a746-c5fe9114d160
Version: 2
Effective Time: 20241015
 
Rugby Laboratories