Label: TEMPRA- acetaminophen syrup
- NDC Code(s): 64613-5800-2
- Packager: Bristol-Myers Squibb de Mexico, S. de R.L. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated May 27, 2016
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
Acetaminophen 160 mg/5 mL
Pain reliever/Fever reducer
- INDICATIONS & USAGE
· temporarily relieves minor aches and pains due to:
· the common cold
· sore throat
- KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF REACH OF CHILDRENClose
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:
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.Close
- DOSAGE & ADMINISTRATION
·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.
under 24 lbs
under 2 years
ask a doctor
*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.
· 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.Close
- INACTIVE INGREDIENT
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
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.
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64613-5800 Route of Administration ORAL 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 10/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/10/2011 10/31/2017 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)