Cimetidine Tablets USP 800mg
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Cimetidine Tablets USP 800mg Technical Specification:

Product Name: Cimetidine Tablets USP 800mg
Brand Name: Generic
Strength: (200mg), (300mg), (400mg), (800mg)
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: Cimetidine is used in the treatment of gastroesophageal reflux disease (acid reflux) and peptic ulcer disease.
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:

  • Cimetidine Tablets USP 200mg
    Each film-coated tablet contains:
    Cimetidine USP……………….200mg
    Excipients…………………………q.s.
    Color: Ferric oxide yellow
  • Cimetidine Tablets USP 300mg
    Each film-coated tablet contains:
    Cimetidine USP……………….300mg
    Excipients…………………………q.s.
    Color: Brilliant Blue FCF
  • Cimetidine Tablets USP 400mg
    Each film-coated tablet contains:
    Cimetidine USP……………….400mg
    Excipients…………………………q.s.
    Color: Lake of Erythrosine
  • Cimetidine Tablets USP 800mg
    Each film-coated tablet contains:
    Cimetidine USP……………….800mg
    Excipients…………………………q.s.
    Color: Sunset Yellow

THERAPEUTIC INDICATIONS:

Cimetidine is used to treat ulcers; gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the food pipe (esophagus); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome.

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, light-resistance containers as defined in the USP.

Dosage: As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Cimetidine Tablets USP 200mg
B) Cimetidine Tablets USP 300mg
C) Cimetidine Tablets USP 400mg
D) Cimetidine Tablets USP 800mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Cimetidine Tablets USP 200mg
Each film coated tablet contains:
Cimetidine USP……………….200mg
Excipients…………………………q.s.
Color: Ferric oxide yellow

B) Cimetidine Tablets USP 300mg
Each film coated tablet contains:
Cimetidine USP……………….300mg
Excipients…………………………q.s.
Color: Brilliant blue FCF

C) Cimetidine Tablets USP 400mg
Each film coated tablet contains:
Cimetidine USP……………….400mg
Excipients…………………………q.s.
Color: Lake of Erythrosine

D) Cimetidine Tablets USP 800mg
Each film coated tablet contains:
Cimetidine USP……………….800mg
Excipients…………………………q.s.
Color: Sunset yellow

THERAPEUTIC INDICATIONS:

Cimetidine is used to treat ulcers; gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the food pipe (esophagus); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome.

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, light resistance containers as defined in the USP.
Dosage: As directed by the Physician