Propranolol Hydrochloride (Page 6 of 6)

Migraine

The initial dose is 80 mg propranolol hydrochloride daily in divided doses. The usual effective dose range is 160 mg to 240 mg per day. The dosage may be increased gradually to achieve optimum migraine prophylaxis. If a satisfactory response is not obtained within four to six weeks after reaching the maximum dose, propranolol hydrochloride therapy should be discontinued. It may be advisable to withdraw the drug gradually over a period of several weeks.

Essential Tremor

The initial dosage is 40 mg propranolol hydrochloride twice daily. Optimum reduction of essential tremor is usually achieved with a dose of 120 mg per day. Occasionally, it may be necessary to administer 240 mg to 320 mg per day.

Hypertrophic Subaortic Stenosis

The usual dosage is 20 mg to 40 mg propranolol hydrochloride three or four times daily before meals and at bedtime.

Pheochromocytoma

The usual dosage is 60 mg propranolol hydrochloride daily in divided doses for three days prior to surgery as adjunctive therapy to alpha-adrenergic blockade. For the management of inoperable tumors, the usual dosage is 30 mg daily in divided doses as adjunctive therapy to alpha-adrenergic blockade.

HOW SUPPLIED

Propranolol Hydrochloride Tablets, USP, 40 mg are green, round, convex, scored tablets, debossed “54” bisect “84” on one side and debossed “V” on the reverse side. They are available as follows:

  • Bottles of 30: 43063-647-30
  • Bottles of 90: 43063-647-90

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a well-closed, light-resistant container as defined in the USP.

Protect from light.

Distributed by:
Par Pharmaceutical
Chestnut Ridge, NY 10977

Mfg. by:
Par Formulations Private Limited,
9/215, Pudupakkam, Kelambakkam — 603 103.
Made in India


Mfg. Lic. No.: TN00002121
OS5482-01-74-01
Issued: 12/2020

PRINCIPAL DISPLAY PANEL — 40 mg

image
(click image for full-size original)

PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-647(NDC:0603-5484)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL) PROPRANOLOL HYDROCHLORIDE 40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C BLUE NO. 2
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color green Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code 54;84;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-647-30 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:43063-647-90 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070219 06/21/2010
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-647)

Revised: 06/2022 PD-Rx Pharmaceuticals, Inc.

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