Imipramine HCl Tablets USP 10mg Technical Specification:
| Product Name: | Imipramine HCl Tablets USP 10mg |
| Brand Name: | Generics |
| Strength: | 10mg, 25mg, 50mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 100s, 500s, 1000s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antidepressant, Central nervous system. |
| Indication: | Imipramine tablets and capsules are used to treat depression. it also used to prevent bedwetting in children. Imipramine is in a class of medications called tricyclic antidepressants. |
| Storage: | Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Imipramine HCl Tablets USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Imipramine HCl Tablets USP 10mg
Each film coated tablet contains:
Imipramine Hydrochloride USP……………….10mg
Excipients……………………………………………. q.s.
Colour: Tartarazine
THERAPEUTIC INDICATIONS:
This medication is used to treat depression. it is also used with other therapies for the treatment of night time bed-wetting (enuresis) in children. using this medication to treat depression may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
| Attach dispensing label as per end country. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
b) Imipramine HCl Tablets USP 25mg
c) Imipramine HCl Tablets USP 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film coated tablet contains:
Imipramine Hydrochloride USP……………….10mg
Excipients……………………………………………. q.s.
Colour: Tartarazine
b) Imipramine HCl Tablets USP 25mg
Each film coated tablet contains:
Imipramine Hydrochloride USP……………….25mg
Excipients……………………………………………. q.s.
Colour: Carmoisine Lake
c) Imipramine HCl Tablets USP 50mg
Each film coated tablet contains:
Imipramine Hydrochloride USP……………….50mg
Excipients…………………………………………. q.s.
Colour: Yellow Iron Oxide
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Dosage: As directed by the Physician.
Attach dispensing label as per end country.

