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Tempra

Bristol-Myers Squibb de Mexico, S. de R.L. de C.V.

Tempra for Adults 500 Acetaminophen


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 500 mg


Purpose

Purpose

Pain reliever/Fever reducer

Uses

Uses  Temporary treatment of mild pain and fever.

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.

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.

Alcohol Warning if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.  Acetaminophen may cause liver damage.

Ask a doctor before use if you have had 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.

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

Keep out of reach of children

Tempra

Directions

Do not take more than directed.

Adults and Children 12 years and over: * Take 1 tablet every 4 hours or 2 tablets every 6 hours, not to exceed 8 tablet in 24 hours.

* Swallow whole - do not crush, chew or dissolve

* Do not take for more than 5 days unless directed by a doctor.

Other Information

* Store between 20 and 25 C (68 - 77 F) avoid high humidity.

* See the right side of the box for lot number and expiration date.

Inactive Ingredients

Hydroxypropyl methylcellulose, Polyethylene Glycol, Polysorbate 80, Pregelatinized starch, Purified Water, Titanium Dioxide, Vanillin

Tempra for Adults

ACETAMINOPHEN 500

PAIN RELIEVER AND FEVER REDUCER

Extra Strength 

20 Tablets

500 mg each

See new warnings information 

Tempra

Tempra

Acetaminophen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64613-5700
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
hydroxypropyl cellulose
polyethylene glycol 400
polysorbate 80
STARCH, CORN
water
titanium dioxide
VANILLIN

Product Characteristics

Color Size Imprint Code Shape
white (white color) 18 mm 500;9239M CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64613-5700-1 20 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2011-03-09


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Be sure to consult your doctor before taking any medication!
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