Famotidine Tablets 10mg Technical Specification:

Product Name:Famotidine Tablets 10mg
Brand Name:PRILOSID AC
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, Antacid, 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:

  • Famotidine Tablets 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Famotidine Tablets 10mg
    Each film coated tablet contains:
    Famotidine B.P. ……………….10mg
    Excipients…………………………q.s.
    Color: Ferric oxide yellow

THERAPEUTIC INDICATIONS:

Famotidine is used to treat stomach ulcers (gastric and duodenal), erosive esophagitis (heartburn or acid indigestion), and gastroesophageal reflux disease (GERD).

CAUTION & WARNING:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH

*Not suitable for children under 3 years.

Acid reducer Tablets.

Read enclosed leaflet before use.

Keep medicine out of reach of children.

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].

Dosage: Recommended dose: Famotidine is a Histamine H2 receptor antagonist. It works by reducing the acid produce in the stomach.

Each tablet for oral administration contains either 20mg or 40mg of famotidine.

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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


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

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

THERAPEUTIC INDICATIONS:

Famotidine is used to treat stomach ulcers (gastric and duodenal), erosive esophagitis (heartburn or acid indigestion), and gastroesophageal reflux disease (GERD).

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
*Not suitable for children under 3 years.
Acid reducer Tablets.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
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].
Dosage: Recommended dose: Famotidine is a Histamine H2 receptor antagonist. It works by reducing the acid produce in the stomach.
Each tablet for oral administration contains either 20mg or 40mg of famotidine.
Attach dispensing label as per end country.