Promethazine Hydrochloride 25 MG Oral Tablet

INDICATIONS AND USAGE 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.

zydus pharmaceuticals usa inc.

FDA Reported Adverse Reactions
`[1] nausea` `[2] fatigue` `[3] toxicity to various agents` `[4] dyspnoea` `[5] headache` `[6] off label use` `[7] diarrhoea` `[8] vomiting` `[9] completed suicide` `[10] pyrexia`

5 months ago

ROUND WHITE Z C 0 2

HOW SUPPLIED

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 68382-040-01 in bottle of 100 tablets NDC 68382-040-05 in bottle of 500 tablets NDC 68382-040-10 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 68382-041-01 in bottle of 100 tablets NDC 68382-041-05 in bottle of 500 tablets NDC 68382-041-10 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 68382-042-01 in bottle of 100 tablets NDC 68382-042-05 in bottle of 500 tablets NDC 68382-042-10 in bottle of 1000 tablets Keep tightly closed. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in light-resistant, tight container.

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