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 160 mg/5 mL
Pain Reliever/Fever Reducer
2-11 years
Strawberry Flavor Syrup
4 fl oz (120 mL)
NDC64613-5800-2
See New Warnings Information and New Dosage Directions

Active Ingredient

Acetaminophen 160 mg/5 mL

Purpose
Pain reliever/Fever reducer

Uses

· temporarily relieves minor aches and pains due to:

· the common cold

· flu

· headache

· sore throat

· toothache

·reduces fever

KEEP OUT OF REACH OF CHILDREN

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. When using this product do not exceed recommended dose (see Overdose warning).

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.

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.

Directions:

·This product does not contain directions or complete warnings for adult use.

·do not give more than directed (see Overdose warning)

·Shake well before using

· mL = milliliter

·find the correct dose on the chart below. if possible, use weight to dose; otherwise use age.

·if needed, repeat dose every 4 hours

·do not give more than 5 times in 24 hours.

Weight (lb)

Age (yr)

Dose (mL)*

under 24 lbs

under 2 years

ask a doctor

24-35 lbs

2-3 years

5 mL

36-47 lbs

4-5 years

7.5 mL

48-59 lbs

6-8 years

10 mL

60-71 lbs

9-10 years

12.5 mL

72-95 lbs

11 years

15mL

*or as directed by your doctor

Attention: use only the enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information

· each 5 mL contains: sodium 4 mg

· store below 30ºC (86ºF)

·avoid high humidity

· tamper evident: do not use if cap seal is torn or broken

· product color may vary 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.

Questions or Comments? call 1-800-721-5072. You may also report side effects to this phone number.

Keep carton for full directions for use.

Manufactured by Bristol-Myers Squibb de Mexico, S de R.L. de C.V. Calzada de Tlalpan No. 2996, Col. Ejido Santa Ursula Coapa, 04870 Mexico D.F.

MADE IN MEXICO.

Tamper evident: do not use if cap seal is torn or broken.

Lot

Expiration Date

Bristol-Myers Squibb

Package Label

1307449A3 jul2015 (2).jpg

TEMPRA 
acetaminophen syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64613-5800
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
STRAWBERRY (UNII: 4J2TY8Y81V)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Color      Score     
Shape Size
Flavor STRAWBERRY (Strawberry Flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64613-5800-2 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/10/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 05/10/2011
Labeler - Bristol-Myers Squibb de Mexico, S. de R.L. de C.V. (823646211)
Establishment
Name Address ID/FEI Business Operations
Bristol-Myers Squibb de Mexico, S. de R.L. de C.V. 823646211 manufacture(64613-5800)

Revised: 12/2015
Document Id: 26185b09-866e-0d7b-e054-00144ff88e88
Set id: ff83bf77-152a-4d1d-93dd-e0f4e072bb9a
Version: 201511
Effective Time: 20151204
 
Bristol-Myers Squibb de Mexico, S. de R.L. de C.V.