pain reliever description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

pain reliever

McKesson (Sunmark)

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Acetaminophen 500 mg

Purpose

Pain reliever/ fever reducer

pain reliever Uses

for the temporarily relief of minor aches and pains associated with: 

  • headache
  • minor arthritis pain 
  • muscular aches
  • backache
  • the common cold
  • pre- menstrual and menstrual cramps
  • toothache
  • temporarily reduces fever

Warnings

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

  • more than 8 softgels in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks ever day while using this product

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: 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not exceed recommended dose

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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

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.

Directions

  • adults and children 12 years and over: take 2 softgels every 6 hours while symptoms last. Do not take more than 8 softgels in 24 hours
  • do not take for more than 10 days unless directed by a doctor
  • children under 12 years of age: do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and could cause serious health problems

pain reliever Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

aerosil 200, D&C Yellow #10, edible ink, gelatin, glycerin USP, povidone K- 30 USP, polyethylene glycol 400 NF, polyethylene glycol 600 NF, propylene glycol USP, Purified water USP, sorbitol special GC, and titanium dioxide USP.

Principal Display Panel

Compare to Extra Strength TYLENOL® ACTIVE INGREDIENT*

SEE NEW WARNINGS INFORMATION

PAIN RELIEVER

Extra Strength

pain reliever & fever reducer

ACETAMINOPHEN 500 mg

Questions or comments ?

call toll free 1-877-753-3935

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

Product Label

pain reliever
Extra strength Pain Reliever

pain reliever

Acetaminophen CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49348-709
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
SILICON DIOXIDE
D&C YELLOW NO. 10
GELATIN
GLYCERIN
POVIDONES
polyethylene glycol 400
POLYETHYLENE GLYCOL 600
propylene glycol
water
sorbitol
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
YELLOW 21 mm APAP500 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 40 in 1 BOTTLE, PLASTIC
2 NDC:49348-709-59 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2010-07-09


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.