Ranitidine Tablets USP 150mg Technical Specification:

Product Name:Ranitidine Tablets USP
Brand Name:Generic
Strength:150mg, 300mg
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:Gastroenterological, Antacid, Anti-Ulcer
Indication: Ranitidine is a medicine that reduces the amount of acid your stomach makes. It was used for indigestion, heartburn and acid reflux, gastro-oesophageal reflux disease (GORD – this is when you keep getting acid reflux), and to prevent and treat stomach ulcers.
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Ranitidine Tablets USP 150mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ranitidine Tablets USP 150mg
    Each film coated tablet contains:
    Ranitidine Hydrochloride USP
    Equivalent to Ranitidine          150mg
    Excipients                                   q.s.
    Colour: Ponceau 4 R

THERAPEUTIC INDICATIONS:

Ranitidine is a medication used to decrease stomach acid production. It is commonly used in treatment of peptic ulcer disease, gastroesophageal reflux disease, and 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].
Protect from light and moisture.
Dosage: As directed by the Physician

Attach dispensing label as per end county.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Ranitidine Tablets USP 150mg
B) Ranitidine Tablets USP 300mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Ranitidine Tablets USP 150mg
Each film coated tablet contains:
Ranitidine Hydrochloride USP
Equivalent to Ranitidine 150mg
Excipients q.s.
Colour: Ponceau 4 R


B) Ranitidine Tablets USP 300mg
Each film coated tablet contains:
Ranitidine Hydrochloride USP
Equivalent to Ranitidine 300mg
Excipients q.s.
Colour: Fast green FCF

THERAPEUTIC INDICATIONS:

Ranitidine is a medication used to decrease stomach acid production. It is commonly used in treatment of peptic ulcer disease, gastroesophageal reflux disease, and 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].
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.