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TEMPRA (acetaminophen) syrup
[Bristol-Myers Squibb de Mexico, S. de R.L. de C.V.]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

Active Ingredient
(In each 5 mL)
Acetaminophen 160 mg

Purpose
Pain reliever/Fever reducer

INDICATIONS AND USAGE

Uses temporarily:

  • Reduces fever
  • Relieves minor aches and pains due to:
  • Common Cold
  • Headache
  • Sore throat
  • Toothache

WARNINGS SECTION

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
* more than 5 doses in 24 hours, which is the maximum daily amount
* with other drugs containing acetaminophen.

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.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomit, consult a doctor promptly.

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 your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if your child has liver disease.

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin.

Stop use and ask a doctor if:

* Pain gets worse or lasts more than 5 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.


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) Prompt 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

DOSAGE AND ADMINISTRATION

Directions:

  • This product does not contain directions or complete warnings for adult use.
  • Shake well before using
  • Find the correct dose on the chart below; if possible, use weight to dose. Otherwise use age
  • Use only the enclosed dispenser for use with this product
  • If needed, repeat dose every 4 hours
  • Do not give more than 5 times in 24 hours
  • Do not give more than 2 days unless directed by a doctor

Do not give more than directed (see overdose warning)

Weight (lb) Age (yr) Dose Children’s TEMPRA Syrup (mL)

34-24 lb 2-3 years 5 mL

35-46 lb 4-5 years 7.5 mL

47-59 lb 6-8 years 10 mL

60-71 lb 9-10 years 12.5 mL

72-95 lb 11 years 15 mL

STORAGE AND HANDLING

Other Information

  • store below 30 C (86 F)
  • do not use if the cap seal is torn or broken
  • see top panel for lot number and expiration date.
  • product color may very slightly over time from pink violet to wine red

Inactive Ingredients
Butylated Hydroxyanisole, Citric Acid, D&C Red No. 33, Polyethylene Glycol, Purified Water, Sodium Chloride, Sodium Citrate, Strawberry and other flavors, Sucrose.

PRINCIPAL DISPLAY PANEL

ESTTEMPRAJBE USA.jpg

INGREDIENTS & APPEARANCE

TEMPRA 
acetaminophen syrup
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:64613-5800
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
CITRIC ACID MONOHYDRATE 
D&C RED NO. 33 
POLYETHYLENE GLYCOL 1450 
WATER 
SODIUM CHLORIDE 
SODIUM CITRATE 
STRAWBERRY 
SUCROSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRY (Strawberry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64613-5800-2120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/10/2011
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(64613-5800)

Revised: 7/2014
 
Bristol-Myers Squibb de Mexico, S. de R.L. de C.V.