EXTRA STRENGTH NON ASPIRIN PAIN RELIEF- acetaminophen tablet 
Stephen L. LaFrance Pharmacy, 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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Select Brand 44-531

Active ingredient (n each tablet)

Acetaminophen 500 mg 

Purpose

Pain reliever/fever reducer 

Uses

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

Warnings

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

  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 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 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: 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 of 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 8 tablets in 24 hours
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: do not use this adult extra strength product in children under 12 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 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, starch, stearic acid, sucralose, talc, titanium dioxide

*may contain this ingredient 

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select brand®

the lower price name brand

NDC 15127-972-24

EXTRA STRENGTH/NON-ASPIRIN

PAIN RELIEVER

ACETAMINOPHEN

Easy to Swallow Sweet Coated

PAIN RELIEVER/FEVER REDUCER • NON-ASPIRIN

†Compare to the Active Ingredient of Tylenol® Extra Strength EZ Tabs

EASY TABS 500 mg Each

24 TABLETS

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Extra Strength EZ Tabs.

50844    REV1010B53108

Distributed by:

SELECT BRAND® DISTRIBUTOR

Pine Bluff, AR 71603

AC (870) 535-3635

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

Select Brand 44-531

Select Brand 44-531

EXTRA STRENGTH NON ASPIRIN PAIN RELIEF 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:15127-972
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
POLYVINYL ALCOHOL 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;531
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-972-081 in 1 CARTON
124 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/11/2005
Labeler - Stephen L. LaFrance Pharmacy, Inc. (043562370)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(15127-972)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(15127-972)

Revised: 8/2012
Document Id: 20295443-3ff4-4b0a-96f8-e6488c72c820
Set id: 6de2e5cd-dd30-4cba-984d-3ef8332a5609
Version: 1
Effective Time: 20120824
 
Stephen L. LaFrance Pharmacy, Inc.