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

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Extra Strength Acetaminophen

Contract Pharmacy Services-PA

Extra Strength Acetaminophen Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen Caplets, 500 mg

PURPOSE

Pain reliever/fever reducer

USES

  • temporarily reduces fever
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • the common cold
    • minor pain of arthritis
    • backache
    • toothache
    • premenstrual and menstrual cramps

WARNINGS

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

  • more than 8 tablets 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.
  • 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.

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). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DIRECTIONS

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
do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

OTHER INFORMATION

store at 15° to 30°C (59° to 86°F)

INACTIVE INGREDIENTS

povidone, pregelatinized starch, stearic acid

QUESTIONS OR COMMENTS?

Distributed by: Marlex Pharmaceuticals, 50 McCullough Drive, New Castle, DE 19720, U.S.A.

call toll free 1-866-820-7381

Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Original--08/2010--NJW

Package Label

Extra Strength Acetaminophen
500 mg Caplets

Extra Strength Acetaminophen

Extra Strength Acetaminophen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67046-027(NDC:10135-144)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg

Product Characteristics

Color Size Shape
WHITE 17 mm OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67046-027-30 30 in 1 BLISTER PACK
2 NDC:67046-027-60 60 in 1 BLISTER PACK
3 NDC:67046-027-62 60 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2010-08-02


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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