Extra Strength Acetaminophen description, usages, side effects, indications, overdosage, supplying and lots more!

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Extra Strength Acetaminophen

Wal-Mart Stores Inc

Equate 44-531A


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Acetaminophen 500 mg 

Purpose

Pain reliever/fever reducer 

Extra Strength Acetaminophen 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) in 24 hours. 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 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 (1-888-222-1222) right away.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs of 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

Extra Strength Acetaminophen Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

corn starch, dextrose monohydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, maltodextrin, povidone, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid, sucralose, titanium dioxide

Questions or comments?

 1-888-287-1915

Principal display panel

NDC 49035-531-12

equate

Compare to Extra Strength Tylenol® EZ Tabs Active Ingredient*

Extra Strength
Acetaminophen
Pain Reliever/Fever Reducer
• Easy tabs - easy to swallow
•Sweet coated

500 mg EACH
100 TABLETS

Distributed by: Wal-Mart Stores, Inc.,
Bentonville, AR 72716
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® EZ Tabs.
50844        REV0913D53112

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 

Extra Strength Acetaminophen
Equate 44-531A

Extra Strength Acetaminophen

Acetaminophen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49035-531
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
STEARIC ACID
FD&C YELLOW NO. 6
FD&C RED NO. 40
STARCH, CORN
talc
titanium dioxide
POLYVINYL ALCOHOL
Dextrose monohydrate

Product Characteristics

Color Size Imprint Code Shape
RED 11 mm 44;531 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 NDC:49035-531-20 225 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-12-11


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Be sure to consult your doctor before taking any medication!
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