ACETAMINOPHEN- acetaminophen tablet 
SUPERVALU INC.

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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Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Liver Warning:

This product contains acetaminophen.  Severe liver damage may occur if:
  • adults take more than 12 tablets in 24 hours, which is the maximum daily amount
  • 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.

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.

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 and children
  • pain gets worse or lasts more than 5 days in children under 12
  • 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: Taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center right away.  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 12
tablets in 24 hours

do not take 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 take for more than 5 days
unless directed by a doctor 
children
under
6 years		do not use this adult regular
strength product in children under
6 years of age; this will provide
more than the recommended dose
(overdose) of acetaminophen and
may cause liver damage 


Other information

  • store at controlled room temperature 15°-30°C (50°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

povidone, starch, stearic acid

Principal Display Panel

equaline®

compare to Regular Strength Tylenol® active ingredient†

NDC 41163-104-12

regular strength

pain relief

• pain reliever/fever reducer

• aspirin free

• acetaminophen, 325 mg

actual size

100 tablets

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

DOES NOT CONTAIN GLUTEN

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademakr Regular Strenth Tylenol®.

50844       REV0112A10412

DISTRIBUTED BY SUPERVALU INC.

EDEN PRARITE, MN 55344 USA

104-12

104-12

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-104
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;104
Contains    
Packaging
#Item CodePackage Description
1NDC:41163-104-121 in 1 CARTON
1100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34307/13/1990
Labeler - SUPERVALU INC. (006961411)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(41163-104)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(41163-104)

Revised: 08/2012
Document Id: 0671f395-afbe-47f9-ad55-579cd57ca6e1
Set id: 39fed213-58a5-42f0-b5c8-7a652590b65f
Version: 1
Effective Time: 20120821
 
SUPERVALU INC.