Phentermine Hydrochloride (Page 3 of 3)

14 CLINICAL STUDIES

In relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with “anorectic” drugs lost more weight on the average than those treated with placebo and diet.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an “anorectic” drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured over several years, whereas the studies cited are restricted to a few weeks’ duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

16 HOW SUPPLIED/STORAGE AND HANDLING

Phentermine hydrochloride tablets USP 37.5 mg (equivalent to 30 mg phentermine base) are white with blue specks, oval shaped, scored on one side and debossed MP 273 on the other side.

Bottles of 30 NDC 53489-676-07
Bottles of 60 NDC 53489-676-06
Bottles of 100 NDC 53489-676-01
Bottles of 250 NDC 53489-676-03
Bottles of 500 NDC 53489-676-05
Bottles of 1000 NDC 53489-676-10

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

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Keep out of the reach of children.

17 PATIENT COUNSELING INFORMATION

Patients must be informed that phentermine hydrochloride is a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity, and that coadministration of phentermine with other drugs for weight loss is not recommended [see Indications and Usage (1) and Warnings and Precautions (5.1)].

Patients must be instructed on how much phentermine to take, and when and how to take it [see Dosage and Administration (2) ].

Advise pregnant women and nursing mothers not to use phentermine [see Use in Specific Populations (8.1, 8.3)].

Patients must be informed about the risks of use of phentermine (including the risks discussed in Warnings and Precautions), about the symptoms of potential adverse reactions and when to contact a physician and/or take other action. The risks include, but are not limited to:

See also, for example, Adverse Reactions (6) and Use in Specific Populations (8).

The patients must also be informed about

Tell patients to keep phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away phentermine may harm others and is against the law.

Regitine® is a registered trademark of CIBA PHARMACEUTICAL PRODUCTS, INC.

Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512

Rev 12, October 2014

Phentermine Hydrochloride Tablets, USP 37.5mg CIV
30 Talets
NDC 10544-552-30

37.5mg 30ct
(click image for full-size original)

PHENTERMINE HYDROCHLORIDE
phentermine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-552(NDC:53489-676)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Phentermine Hydrochloride (Phentermine) Phentermine 30 mg
Inactive Ingredients
Ingredient Name Strength
crospovidone
calcium phosphate, dibasic, dihydrate
FD&C Blue No. 1
magnesium stearate
povidones
Product Characteristics
Color WHITE (with blue specks) Score 2 pieces
Shape OVAL Size 13mm
Flavor Imprint Code MP;273
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-552-30 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:10544-552-45 45 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:10544-552-60 60 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040526 10/21/2013
Labeler — Blenheim Pharmacal, Inc. (171434587)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 repack (10544-552)

Revised: 07/2015 Blenheim Pharmacal, Inc.

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