TEMPRA- acetaminophen syrup 
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 for Children Acetaminophen 2-11 years

Active Ingredient
(In each 5 mL)
Acetaminophen 160 mg

Purpose
Pain reliever/Fever reducer

Uses temporarily:

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

Directions:

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

Other Information

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

ESTTEMPRAJBE USA.jpg

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
Document Id: d542a0fa-d9eb-4741-9369-019a4e837232
Set id: ff83bf77-152a-4d1d-93dd-e0f4e072bb9a
Version: 1010
Effective Time: 20140723
 
Bristol-Myers Squibb de Mexico, S. de R.L. de C.V.