PROMETHAZINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)

Available from:

Zydus Lifesciences Limited

INN (International Name):

PROMETHAZINE HYDROCHLORIDE

Composition:

PROMETHAZINE HYDROCHLORIDE 12.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

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

Summary of Product characteristics

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 -