DrugCite

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

Tempra for Adults 500 Acetaminophen

Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 500 mg


Purpose

Pain reliever/Fever reducer

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

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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 

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TEMPRA 
acetaminophen  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 64613-5700
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (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 white (white color) Score no score
Shape CAPSULE (Capsule shaped) Size 18mm
Flavor Imprint Code 500;9239M
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 64613-5700-1 20 BLISTER In 1 BOX None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 03/09/2022

Labeler - Bristol-Myers Squibb de Mexico, S. de R.L. de C.V. (823646211)
Establishment
Name Address ID/FEI Operations
Bristol-Myers Squibb de Mexico, S. de R.L. de C.V. 823646211 manufacture
Revised: 03/2011Bristol-Myers Squibb de Mexico, S. de R.L. de C.V.