SHOPRITE NON-ASPIRIN- acetaminophen tablet 
Wakefern Food Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ShopRite Non-Aspirin 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-SHOPRITE

Principal Display Panel

Compare to: Active Ingredient in Tylenol®

REGULAR STRENGTH

NON-ASPIRIN

Acetaminophen 325 mg each

Pain Reliever/Fever Reducer – Aspirin Free

actual size

100 TABLETS

4038B-non-aspirin-image1.jpg
4038B-non-aspirin-image2.jpg
SHOPRITE NON-ASPIRIN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41190-520
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)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
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:41190-520-781 in 1 CARTON12/07/201612/31/2020
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/07/201612/31/2020
Labeler - Wakefern Food Corporation (069722418)

Revised: 12/2020
Document Id: ea5042d0-48fc-482a-a05f-8871f20da839
Set id: f5dc9fe4-18fb-4751-adc9-85eb93b1bec5
Version: 4
Effective Time: 20201201
 
Wakefern Food Corporation