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.

----------

Equaline 44-104

Active ingredient (in each tablet)

Acetaminophen 325 mg

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:

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 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 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

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

Inactive ingredients

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

*may contain this ingredient

Principal Display Panel

equaline®

compare to Regular Strength Tylenol® active ingredient†

NDC 41163-104-12

regular strength

pain relief

• acetaminophen, 325 mg 

• pain reliever/fever reducer

• aspirin free

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       REV0112C10412

DISTRIBUTED BY SUPERVALU INC.
EDEN PRARIE, MN 55344 USA

Equaline 44-104

Equaline 44-104


ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 
STARCH, CORN 
POVIDONES 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;104
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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 NOT 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: 7/2013
Document Id: 3d00ba8d-7cb5-4168-a544-68cca68bb3c5
Set id: 39fed213-58a5-42f0-b5c8-7a652590b65f
Version: 3
Effective Time: 20130717
 
SUPERVALU INC.