Extra Strength Non-Aspirin Pain Reliever

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Stephen L. LaFrance Pharmacy, Inc.
NDC Code: 15127-730

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.

Select Brand 44-148

Active ingredient (in 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. The maximum daily dose of this product is 6 tablets (3,000 mg). Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours

  • 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 are

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 (1-800-222-1222) 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 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 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

povidone, pregelatinized starch, stearic acid

Questions or comments?

1-800-426-9391

Principal Display Panel

select brand®
the lower price name brand

NDC 15127-730-30

EXTRA STRENGTH/NON-ASPIRIN
PAIN RELIEVER
ACETAMINOPHEN
PAIN RELIEVER/FEVER REDUCER • NON-ASPIRIN

SAFETY SEALED

*Compare to the Active Ingredient of Extra Strength Tylenol®

500 mg EACH

30 TABLETS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.
50844         REV0213C14812

Distributed by:
SELECT BRAND® DISTRIBUTORS
Pine Bluff, AR 71603 USA
AC (870) 535-3635

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

Select Brand 44-148

EXTRA STRENGTH NON-ASPIRIN PAIN RELIEVER 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-730
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONES 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize13mm
FlavorImprint Code44;148
Contains    
Packaging
#Item CodePackage Description
1NDC:15127-730-301 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
130 TABLET (30 TABLET) in 1 BOTTLE, PLASTIC
2NDC:15127-730-061 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
260 TABLET (60 TABLET) in 1 BOTTLE, PLASTIC
3NDC:15127-730-211 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
3100 TABLET (100 TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/21/1993
Labeler - Stephen L. LaFrance Pharmacy, Inc. (043562370)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(15127-730)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(15127-730)

Revised: 05/2013
 
Stephen L. LaFrance Pharmacy, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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