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
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- ACTIVE INGREDIENT
(In each 5 mL)
Acetaminophen 160 mg
Pain reliever/Fever reducer
- INDICATIONS & USAGE
- Reduces fever
- Relieves minor aches and pains due to:
- Common Cold
- Sore throat
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
Keep out of reach of childrenClose
- DOSAGE & ADMINISTRATION
- 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 mLClose
- STORAGE AND HANDLING
- 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 INGREDIENT
Butylated Hydroxyanisole, Citric Acid, D&C Red No. 33, Polyethylene Glycol, Purified Water, Sodium Chloride, Sodium Citrate, Strawberry and other flavors, Sucrose.
- INGREDIENTS AND APPEARANCE
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 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)