Chlordiazepoxide Tablets USP 25mg

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Chlordiazepoxide Tablets USP 5mg
 B. Chlordiazepoxide Tablets USP 10mg
C. Chlordiazepoxide Tablets USP 25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Chlordiazepoxide Tablets USP 5mg
Each Sugar coated tablet contains:
Chlordiazepoxide USP……….……5mg
Excipients……………………………..q.s
Colour: Sunset yellow FCF

 B. Chlordiazepoxide Tablets USP 10mg
Each Sugar coated tablet contains:
Chlordiazepoxide USP……….……10mg
Excipients………………………………..q.s
Colour: Sunset yellow

C. Chlordiazepoxide Tablets USP 25mg
Each Sugar coated tablet contains:
Chlordiazepoxide USP……….……25mg
Excipients………………………………..q.s
Colour: Sunset yellow lake

THERAPEUTIC INDICATIONS:

Chlordiazepoxide is used to relieve symptoms of anxiety, including nervousness or anxiety that happens before a surgery. It may also be used to treat symptoms of alcohol withdrawal. Chlordiazepoxide is a benzodiazepine.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT, CHILD-RESISTANT CONTAINER AS DEFINED IN THE USP.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT IN ACCORDANCE WITH MEDICAL ADVICE.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.

Chlordiazepoxide Tablets USP 25mg Technical Specification:

Product Name:Chlordiazepoxide Tablets USP
Brand Name:Generic
Strength:(5mg), (10mg), (25mg)
Dosage Form:Tablets (Sugar coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Sedative-hypnotics
Indication: Chlordiazepoxide is used to relieve symptoms of anxiety, including nervousness or anxiety that happens before surgery. It may also be used to treat symptoms of alcohol withdrawal. Chlordiazepoxide is a benzodiazepine.
Storage:Store at 20° to 25°C (68° to 77°F). Store in dry place protected from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Chlordiazepoxide Tablets USP 5mg
  • Chlordiazepoxide Tablets USP 10mg
  • Chlordiazepoxide Tablets USP 25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Chlordiazepoxide Tablets USP 5mg
    Each Sugar coated tablet contains:
    Chlordiazepoxide USP……….……5mg
    Excipients……………………………..q.s
    Colour: Sunset yellow FCF
  • Chlordiazepoxide Tablets USP 10mg
    Each Sugar coated tablet contains:
    Chlordiazepoxide USP……….……10mg
    Excipients………………………………..q.s
    Colour: Sunset Yellow
  • Chlordiazepoxide Tablets USP 25mg
    Each Sugar coated tablet contains:
    Chlordiazepoxide USP……….……25mg
    Excipients………………………………..q.s
    Colour: Sunset yellow lake

THERAPEUTIC INDICATIONS:

Chlordiazepoxide is used to relieve symptoms of anxiety, including nervousness or anxiety that happens before surgery. It may also be used to treat symptoms of alcohol withdrawal. Chlordiazepoxide is a benzodiazepine.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT, CHILD-RESISTANT CONTAINER AS DEFINED IN THE USP.IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT IN ACCORDANCE WITH MEDICAL ADVICE.
Warning: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician.
Attach dispensing label as per end country.