Benzonatate (Page 2 of 2)

DOSAGE AND ADMINISTRATION

Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate Capsules should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.

HOW SUPPLIED

Benzonatate Capsules USP , 100 mg are available as yellow, oval soft gelatin capsules with ‘1’ imprinted in white ink.
Bottles of 100: NDC 51224-010-50
Bottles of 500: NDC 51224-010-60


Benzonatate Capsules USP , 200 mg are available as yellow, oval soft gelatin capsules with ‘2’ imprinted in white ink.
Bottles of 100: NDC 51224-001-50
Bottles of 500: NDC 51224-001-60

Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

PROTECT FROM LIGHT

Rev. 2616

Manufactured by:
CSPC-NBP Pharmaceutical Co., Ltd.
Shijiazhuang, Hebei, China, 052160

Manufactured for:
TAGI Pharma, Inc.
South Beloit, IL 61080

PRINCIPAL DISPLAY PANEL — 100 mg Capsule Bottle Label

NDC 51224-010-50

Benzonatate
Capsules USP

100 mg

Rx only

100 CAPSULES

CSPC®

tagiPHARMA
That’s A Good Idea.

PRINCIPAL DISPLAY PANEL -- 100 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mg Capsule Bottle Label

NDC 51224-001-50

Benzonatate
Capsules USP

200 mg

Rx only

100 CAPSULES

CSPC®

tagiPHARMA
That’s A Good Idea.

PRINCIPAL DISPLAY PANEL -- 200 mg Capsule Bottle Label
(click image for full-size original)
BENZONATATE
benzonatate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51224-010
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZONATATE (BENZONATATE) BENZONATATE 100 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
GELATIN, UNSPECIFIED
GLYCERIN
METHYLPARABEN
PROPYLPARABEN
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape OVAL Size 8mm
Flavor Imprint Code 1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51224-010-50 100 CAPSULE in 1 BOTTLE None
2 NDC:51224-010-60 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202765 09/07/2017
BENZONATATE
benzonatate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51224-001
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZONATATE (BENZONATATE) BENZONATATE 200 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
GELATIN, UNSPECIFIED
GLYCERIN
METHYLPARABEN
PROPYLPARABEN
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape OVAL Size 11mm
Flavor Imprint Code 2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51224-001-50 100 CAPSULE in 1 BOTTLE None
2 NDC:51224-001-60 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202765 08/10/2015
Labeler — TAGI Pharma, Inc. (963322560)
Registrant — CSPC-NBP Pharmaceutical Co., Ltd. (723645870)
Establishment
Name Address ID/FEI Operations
CSPC-NBP Pharmaceutical Co., Ltd. 723645870 manufacture (51224-010), manufacture (51224-001)

Revised: 06/2022 TAGI Pharma, Inc.

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