Your browser does not support JavaScript! PAIN RELIEVER (ACETAMINOPHEN) TABLET [STEPHEN L. LAFRANCE PHARMACY, INC.]
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RxNorm Names

PAIN RELIEVER (acetaminophen) tablet
[Stephen L. LaFrance Pharmacy, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 25°C (77°F); excursions permitted 15º-30ºC (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

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

*may contain this ingredient

Principal Display Panel

select brand®
the lower price name brand

NDC 15127-072-24

REGULAR STRENGTH/NON-ASPIRIN

PAIN RELIEVER
ACETAMINOPHEN

SAFETY SEALED

†Compare to the Active Ingredient of Regular Strength Tylenol®

325 mg Each

100 TABLETS

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

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Regular Strength Tylenol®.
50844         REV0112B10408

Distributed by:
SELECT BRAND® DISTRIBUTORS
Pine Bluff, AR 71603 USA

Select Brand 44-104

Select Brand 44-104


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PAIN RELIEVER 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-072
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONES 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;104
Contains    
Packaging
#Item CodePackage Description
1NDC:15127-072-081 in 1 CARTON
1100 in 1 BOTTLE, PLASTIC
2NDC:15127-072-241 in 1 CARTON
224 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/13/1990
Labeler - Stephen L. LaFrance Pharmacy, Inc. (043562370)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(15127-072)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(15127-072)

Revised: 10/2012
Document Id: 1008dbd9-455a-4fd8-ab08-6978f7c0546f
Set id: ca7ae149-4c3f-449f-8536-c1135f04479a
Version: 11
Effective Time: 20121006
 
Stephen L. LaFrance Pharmacy, Inc.

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