TETRACYCLINE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T)

Available from:

Bryant Ranch Prepack

INN (International Name):

TETRACYCLINE HYDROCHLORIDE

Composition:

TETRACYCLINE HYDROCHLORIDE 500 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TETRACYCLINE HYDROCHLORIDE- TETRACYCLINE HYDROCHLORIDE CAPSULE
BRYANT RANCH PREPACK
----------
TETRACYCLINE
HYDROCHLORIDE
CAPSULES, USP
REVISED: APRIL 2010
RX ONLY
2001074-00
DES CRIPTION:
Tetracycline is a yellow, odorless, crystalline powder. Tetracycline
is stable in air but exposure to
strong sunlight causes it to darken. Its potency is affected in
solutions of pH below 2 and is rapidly
destroyed by alkali hydroxide solutions.
Tetracycline is very slightly soluble in water, freely soluble in
dilute acid and in alkali hydroxide
solutions, sparingly soluble in alcohol, and practically insoluble in
chloroform and in ether.
Each capsule, for oral administration, contains tetracycline
hydrochloride 250 mg or 500 mg.
INACTIVE INGREDIENTS: Lactose, magnesium stearate, and sodium lauryl
sulfate.
The 250 mg capsule shell contains D&C yellow no. 10, FD&C yellow no.
6, gelatin, sodium lauryl
sulfate, and titanium dioxide. It may also contain benzyl alcohol,
butylparaben, D&C red no. 22, edentate
calcium disodium, methylparaben, propylparaben, silicon dioxide, and
sodium propionate.
The imprinting ink for the 250 mg capsule contains pharmaceutical
glaze, and synthetic black iron oxide.
It may also contain D&C yellow no. 10 (aluminum lake),
dimethylpolysiloxane, distilled water, ethylene
glycol monoethyl ether, FD&C blue no. 1 (aluminum lake), FD&C blue no.
2 (aluminum lake), FD&C
red no. 40 (aluminum lake), lecithin, n-butyl alcohol, propylene
alcohol, and SDA-3A alcohol.
The 500 mg capsule shell contains D&C yellow no. 10, FD&C blue no.1,
FD&C red no. 40, gelatin,
sodium lauryl sulfate, and titanium dioxide. It may also contain
benzyl alcohol, butylparaben, edetate
calcium disodium, FD&C yellow no. 6, methylparaben, propylparaben,
silicon dioxide, and sodium
propionate.
The imprinting ink for the 500 mg capsule contains titanium dioxide.
It may also contain dimethyl
polysiloxane, distilled water, ethyl alcohol, ethylene glycol
monoethyl ether, pharmaceutical glaze,
pharmaceutical shellac, and soya lecithin.
The structur