Phenobarbital (Page 2 of 2)

Treatment

General management should consist of symptomatic and supportive therapy, including gastric lavage, administration of intravenous fluids, and maintenance of blood pressure, body temperature and adequate respiratory exchange. Dialysis will increase the rate of removal of barbiturates from the body fluids. Antibiotics may be required to control pulmonary complications.

DOSAGE AND ADMINISTRATION

Oral Sedative Dose

Adults: 30 to 120 mg daily in 2 or 3 divided doses.

Children: 6 mg/kg of body weight daily in 3 divided doses.

Oral Hypnotic Dose

Adults: 100 to 320 mg.

Oral Anticonvulsant Dose,

Adults: 50 to 100 mg 2 or 3 times daily.

Children: 15 to 50 mg 2 or 3 times daily.

HOW SUPPLIED

Phenobarbital Tablets USP, 15 mg

White, Round Tablet; Debossed “WW 445” on one side and plain on the other side.

NDC 0143-1495-01: Bottle of 100 tablets
NDC 0143-1495-05: Bottle of 500 tablets

Phenobarbital Tablets USP, 30 mg

White, Round, Scored Tablet; Debossed “WW 450” on one side and Scored on the other side.

NDC 0143-1500-01: Bottle of 100 tablets
NDC 0143-1500-05: Bottle of 500 tablets

Phenobarbital Tablets USP, 60 mg

White, Round Tablet; Debossed “WW 455” on one side and plain on the other side.

NDC 0143-1455-01: Bottle of 100 tablets
NDC 0143-1455-05: Bottle of 500 tablets

Phenobarbital Tablets USP, 100 mg

White, Round, Scored Tablet; Debossed “WW 458” on one side and Scored on the other side.

NDC 0143-1458-01: Bottle of 100 tablets
NDC 0143-1458-05: Bottle of 500 tablets

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

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Distributed by:
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922

C50000803/02 Revised August 2022

PRINCIPAL DISPLAY PANEL

NDC 0143-1495-01
Phenobarbital Tablets USP
15 mg
100 Tablets Rx Only

NDC 0143-1495-01 Phenobarbital Tablets, USP 15 mg 100 Tablets Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0143-1500-01
Phenobarbital Tablets USP
30 mg
100 Tablets Rx Only

NDC 0143-1500-01 Phenobarbital Tablets, USP 30 mg 100 Tablets Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0143-1455-01
Phenobarbital Tablets USP
60 mg
100 Tablets Rx Only

NDC 0143-1455-01 Phenobarbital Tablets, USP 60 mg 100 Tablets Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0143-1458-01
Phenobarbital Tablets USP
100 mg
100 Tablets Rx Only

ndc-0143-1458-01-100tabs-pheno100mg.jpg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

blank-image.jpgblank-image.jpg

PRINCIPAL DISPLAY PANEL

pheno-new-image.jpgpheno-new-image.jpg
PHENOBARBITAL phenobarbital tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-1495
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 15 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
SILICON DIOXIDE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code WW;445
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-1495-05 500 TABLET in 1 BOTTLE None
2 NDC:0143-1495-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/05/2020
PHENOBARBITAL phenobarbital tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-1500
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 30 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
STARCH, CORN
DOCUSATE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code WW;450
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-1500-05 500 TABLET in 1 BOTTLE None
2 NDC:0143-1500-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/05/2020
PHENOBARBITAL phenobarbital tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-1455
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 60 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
STARCH, CORN
DOCUSATE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code WW;455
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-1455-05 500 TABLET in 1 BOTTLE None
2 NDC:0143-1455-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/11/1999
PHENOBARBITAL phenobarbital tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-1458
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
STARCH, CORN
DOCUSATE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code WW;458
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-1458-05 500 TABLET in 1 BOTTLE None
2 NDC:0143-1458-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/07/2000
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 12/2023 Hikma Pharmaceuticals USA Inc.

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