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

NDC: 71335-1968-1: 30 Tablets in a BOTTLE

NDC: 71335-1968-2: 20 Tablets in a BOTTLE

NDC: 71335-1968-3: 100 Tablets in a BOTTLE

NDC: 71335-1968-4: 15 Tablets in a BOTTLE

NDC: 71335-1968-5: 120 Tablets in a BOTTLE

NDC: 71335-1968-6: 60 Tablets in a BOTTLE

NDC: 71335-1968-7: 90 Tablets in a BOTTLE

NDC: 71335-1968-8: 14 Tablets in a BOTTLE

NDC: 71335-1968-9: 40 Tablets in a BOTTLE

NDC: 71335-1968-0: 10 Tablets in a BOTTLE

Rev. 2616

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

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

Benzonatate Capsule 100mg Caps.

Label
(click image for full-size original)
BENZONATATE
benzonatate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-1968(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:71335-1968-1 30 CAPSULE in 1 BOTTLE None
2 NDC:71335-1968-2 20 CAPSULE in 1 BOTTLE None
3 NDC:71335-1968-3 100 CAPSULE in 1 BOTTLE None
4 NDC:71335-1968-4 15 CAPSULE in 1 BOTTLE None
5 NDC:71335-1968-5 120 CAPSULE in 1 BOTTLE None
6 NDC:71335-1968-6 60 CAPSULE in 1 BOTTLE None
7 NDC:71335-1968-7 90 CAPSULE in 1 BOTTLE None
8 NDC:71335-1968-8 14 CAPSULE in 1 BOTTLE None
9 NDC:71335-1968-9 40 CAPSULE in 1 BOTTLE None
10 NDC:71335-1968-0 10 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
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (71335-1968), RELABEL (71335-1968)

Revised: 12/2021 Bryant Ranch Prepack

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