País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)
Zydus Lifesciences Limited
PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE 12.5 mg
ORAL
PRESCRIPTION DRUG
Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients. Promethazine hydrochloride tablets, USP are contraindicated for use
Promethazine hydrochloride tablets USP, 12.5 mg are white to off-white, round shape, biconvex, uncoated tablets debossed with the logo of "ZC", "01" and bisect on one side and plain on the other side and are supplied as follows: NDC 65841-040-01 in bottle of 100 tablets NDC 65841-040-05 in bottle of 500 tablets NDC 65841-040-10 in bottle of 1000 tablets Promethazine hydrochloride tablets USP, 25 mg are white to off-white, round shape, biconvex, uncoated tablets debossed with the quadrisect and the logo of "Z", "C", "0" and "2" on one side and plain on the other side and are supplied as follows: NDC 65841-041-01 in bottle of 100 tablets NDC 65841-041-05 in bottle of 500 tablets NDC 65841-041-10 in bottle of 1000 tablets Promethazine hydrochloride tablets USP, 50 mg are white to off-white, round shape, biconvex, uncoated tablets debossed with the logo of "ZC03" on one side and plain on the other side and are supplied as follows: NDC 65841-042-01 in bottle of 100 tablets NDC 65841-042-05 in bottle of 500 tablets NDC 65841-042-10 in bottle of 1000 tablets Keep tightly closed. Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in light-resistant, tight container.
Abbreviated New Drug Application
PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET Cadila Healthcare Limited ---------- This is a summary of the most important information about promethazine. For details, talk to your healthcare professional. WHAT IS PROMETHAZINE? Promethazine is an antihistamine which can be taken by mouth as a tablet or syrup, rectally as a suppository, or by injection. It can be used for: • "hay fever," or, a stuffy runny nose from allergy • watery, itchy eyes due to inhaled allergies and foods • mild allergic skin reactions with itching and swelling • allergic reactions to blood or plasma • dermographism, a form of hives known as "skin writing" • serious allergic reactions along with epinephrine and other treatments • sedation before or after surgery, or during childbirth • prevention and control of nausea and vomiting after surgery • along with meperidine (demerol) or other pain medicines • sedation, relief of anxiety, and production of light sleep • from which the patient can be easily aroused • treatment and prevention of motion sickness WHO SHOULD NOT USE PROMETHAZINE? Promethazine should not be given to: • children under two years of age • patients who are unconscious • patients who are allergic to promethazine, any of the ingredients in promethazine, or to other phenothiazines • patients with lung symptoms including asthma • children who are vomiting unless the vomiting is prolonged and there is a known cause WHAT ARE THE RISKS? The following are the major potential risks and side effects of promethazine therapy. However, this list is not complete. • Severe drowsiness and reduced mental alertness. Promethazine may cause drowsiness which may impair your ability to ride a bike, drive a car, or operate machinery. This may be worsened if taken with alcohol or other drugs that also cause central nervous system (CNS) slowing such as sedatives, pain medicines, tranquilizers or certain drugs for depression. • Serious breathing problems. Promethazine should not be used in patien Leer el documento completo
PROMETHAZINE HYDROCHLORIDE - PROMETHAZINE HYDROCHLORIDE TABLET ZYDUS LIFESCIENCES LIMITED ---------- PROMETHAZINE HYDROCHLORIDE TABLETS USP PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-040-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 12.5 mg R only 100 tablets NDC 65841-041-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 25 mg R only 100 tablets x x NDC 65841-042-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 50 mg R only 100 tablets PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride tablet PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:65841-040 ROUTE OF ADMINISTRATION ORAL x ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZ INE HYDROCHLORIDE 12.5 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) PRODUCT CHARACTERISTICS COLOR WHITE (WHITE TO OFF-WHITE) SCORE 2 pieces SHAPE ROUND (ROUND) SIZE 6mm FLAVOR IMPRINT CODE Z C;01 CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:65841-040- 01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2005 2 NDC:65841-040- 05 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2005 3 NDC:65841-040- 10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2005 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE ANDA ANDA040596 12/14/2005 PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride tablet PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:65841-041 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - Leer el documento completo