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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Tempra
ACETAMINOPHEN 500mg
Pain Reliever / Fever Reducer
Extra Strength
Adults

Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever / fever reducer

Uses

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

Warnings

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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.
  • 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
  • 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

Directions

  • do not take more than directed (see Overdose warning)
  • adults and children 12 years and over: take 2 tablets (1,000 mg) every 6 hours while symptoms last
  • do not take more than 6 tablets (3,000) mg in 24 hours, unless directed by a doctor
  • swallow whole - do not crush, chew or dissolve
  • do not take for more than 10 days unless directed by a doctor.
  • children under 12 years: do not use

Other Information

  • Store in a cool dry place
  • Store below 30°C (86°F)

Inactive Ingredients

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

Questions or Comments? Call 1-800-721-5072

Tempra

ACETAMINOPHEN 500 mg

PAIN RELIEVER / FEVER REDUCER

Extra Strength

Adults

20 Tablets

See new warnings information

NDC 64613-5700-1

Contains no Aspirin

Tamper evident: product is sealed in blister package for your protection. Do not use if carton is damaged or if printed seal on blister is broken or missing.

Lot:

Expiration Date:

1338298A0 est tempra tab USA DM_package.jpeg1338334A0 alu tempra tab USA DM_blister.jpeg

TEMPRA 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64613-5700
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, CORN (UNII: O8232NY3SJ)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
VANILLIN (UNII: CHI530446X)  
Product Characteristics
Colorwhite (white color) Scoreno score
ShapeCAPSULE (Capsule shaped) Size18mm
FlavorImprint Code 500;9239M
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64613-5700-120 in 1 BOX; Type 0: Not a Combination Product03/09/201101/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/09/201101/20/2018
Labeler - Bristol-Myers Squibb de Mexico, S. de R.L. de C.V. (823646211)
Establishment
NameAddressID/FEIBusiness Operations
Bristol-Myers Squibb de Mexico, S. de R.L. de C.V.823646211manufacture(64613-5700)

Revised: 5/2016
 
Bristol-Myers Squibb de Mexico, S. de R.L. de C.V.