Famotidine Tablets USP 20mg
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Famotidine Tablets USP 20mg Technical Specification:

Product Name: Famotidine Tablets USP 20mg
Brand Name: Generic
Strength: (10mg), (20mg), (40mg)
Dosage Form: Tablets (Film-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: Anti-Ulcer, Gastroenterological
Indication: Famotidine is used to treat stomach ulcers (gastric and duodenal), erosive esophagitis (heartburn or acid indigestion), and gastroesophageal reflux disease (GERD).
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Famotidine Tablets USP 10mg
    Each film-coated tablet contains:
    Famotidine USP……………….10mg
    Excipients…………………………q.s.
    Color: Ferric oxide yellow
  • Famotidine Tablets USP 20mg
    Each film-coated tablet contains:
    Famotidine USP……………….20mg
    Excipients…………………………q.s.
    Color: Brilliant Blue FCF
  • Famotidine Tablets USP 40mg
    Each film-coated tablet contains:
    Famotidine USP……………….40mg
    Excipients…………………………q.s.
    Color: Lake of Erythrosine

THERAPEUTIC INDICATIONS:

famotidine is used to prevent and treat heartburn due to acid indigestion and sour stomach caused by eating or drinking certain foods or drinks. Famotidine is in a class of medications called H2 blockers. It works by decreasing the amount of acid made in the stomach. 

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 at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight container.

Dosage: As directed by the Physician

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Famotidine Tablets USP 10mg
B) Famotidine Tablets USP 20mg
C) Famotidine Tablets USP 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Famotidine Tablets USP 10mg
Each film coated tablet contains:
Famotidine USP……………….10mg
Excipients…………………………q.s.
Color: Ferric oxide yellow

B) Famotidine Tablets USP 20mg
Each film coated tablet contains:
Famotidine USP……………….20mg
Excipients…………………………q.s.
Color: Brilliant blue FCF

C) Famotidine Tablets USP 40mg
Each film coated tablet contains:
Famotidine USP……………….40mg
Excipients…………………………q.s.
Color: Lake of Erythrosine

THERAPEUTIC INDICATIONS:

famotidine is used to prevent and treat heartburn due to acid indigestion and sour stomach caused by eating or drinking certain foods or drinks. Famotidine is in a class of medications called H2 blockers. It works by decreasing the amount of acid made in the stomach.

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 at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Dosage: As directed by the Physician