Extra Strength Non-Aspirin Pain Reliever description, usages, side effects, indications, overdosage, supplying and lots more!

Extra Strength Non-Aspirin Pain Reliever

Stephen L. LaFrance Pharmacy, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Select Brand 44-148

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Principal Display Panel
Select Brand 44-148

Extra Strength Non-Aspirin Pain Reliever

Acetaminophen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:15127-730
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg

Inactive Ingredients

Ingredient Name Strength
POVIDONES
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
WHITE 13 mm 44;148 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE, PLASTIC
2 60 in 1 BOTTLE, PLASTIC
3 100 in 1 BOTTLE, PLASTIC
4 NDC:15127-730-21 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1993-01-21


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Be sure to consult your doctor before taking any medication!
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