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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Uses
· temporarily relieves minor aches and pains due to:
· the common cold
· flu
· headache
· sore throat
· toothache
·reduces fever
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
TEMPRA
acetaminophen syrup |
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Labeler - Bristol-Myers Squibb de Mexico, S. de R.L. de C.V. (823646211) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Bristol-Myers Squibb de Mexico, S. de R.L. de C.V. | 823646211 | manufacture(64613-5800) |