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Name:Acetaminophen
Manufacturer:Stephen L. Lafrance Pharmacy, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Pain Reliever

ACETAMINOPHEN - 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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Pain Reliever

Drug Facts

Active ingredient

Acetaminophen 500 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

Warning

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

  • more then 8 caplets 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 or symptoms.

Directions

  • do not take more than directed

(see overdose warning)

  • adults and children 12 years and over
  • take 2 caplets every 4 to 6 hours while symptoms last
  • do not take more than 8 caplets 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 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive Ingredients

caster oil, hypromellose, povidone, sodium starch glycolate*, starch, stearic acid

*may contain this ingredient

Questions or comments?

1-800-426-9391

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currenly in use. Additional packaging may also be available.

select brand®

the lower price name brand

EXTRA STRENGTH/NON-ASPRIN

PAIN RELIEVER

NDC 15127-735-08

SEE NEW WARNINGS

SAFETY SEALED

PAIN RELIEVER/FEVER REDUCER

NON-ASPRIN ACETAMINOPHEN

†Compare to the active Ingredient of Extra Strength Tylenol®

500 mg EACH

100 CAPLETS

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

50844         ORG070917512

Distributed by:

SELECT BRAND® DISTRIBUTORS

Pine Bluff, AR 71603 USA

AC (870) 535-3635

Product Label

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:15127-175
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES  
POVIDONE  
STEARIC ACID  
CASTOR OIL  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
Product Characteristics
Color WHITE Score no score
Shape CAPSULE (Tablet) Size 18mm
Flavor Imprint Code 44;175
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15127-175-08 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
1 24 TABLET (24 TABLET) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (15127-175-08)
2 NDC:15127-175-15 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
2 50 TABLET (50 TABLET) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (15127-175-15)
3 NDC:15127-175-12 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
3 100 TABLET (100 TABLET) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (15127-175-12)
4 NDC:15127-175-14 500 TABLET (500 TABLET) in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 04/02/1993

Labeler - Stephen L. LaFrance Pharmacy, Inc. (043562370)

Revised: 02/2011 Stephen L. LaFrance Pharmacy, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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