GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Olmesartan Medoxomil Tablets USP 5mg
B. Olmesartan Medoxomil Tablets USP 20mg
C. Olmesartan Medoxomil Tablets USP 40mg
B. Olmesartan Medoxomil Tablets USP 20mg
C. Olmesartan Medoxomil Tablets USP 40mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Olmesartan Medoxomil Tablets USP 5mg
Each film-coated tablet contains:
Olmesartan Medoxomil USP 5mg
Excipients q.s
Color: Sunset yellow FCF
B. Olmesartan Medoxomil Tablets USP 20mg
Each film-coated tablet contains:
Olmesartan Medoxomil USP 20mg
Excipients q.s
Color: Ponceau 4R
C. Olmesartan Medoxomil Tablets USP 40mg
Each film-coated tablet contains:
Olmesartan Medoxomil USP 40mg
Excipients q.s
Color: Ponceau 2R
Each film-coated tablet contains:
Olmesartan Medoxomil USP 5mg
Excipients q.s
Color: Sunset yellow FCF
B. Olmesartan Medoxomil Tablets USP 20mg
Each film-coated tablet contains:
Olmesartan Medoxomil USP 20mg
Excipients q.s
Color: Ponceau 4R
C. Olmesartan Medoxomil Tablets USP 40mg
Each film-coated tablet contains:
Olmesartan Medoxomil USP 40mg
Excipients q.s
Color: Ponceau 2R
THERAPEUTIC INDICATIONS:
Olmesartan is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Olmesartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so that blood can flow more easily.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight, light-resistant container as defines in the USP using a child-resistant closure.
Keep container tightly closed.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
When pregnancy is detected, Olmesartan should be discontinued as soon as possible, as it can cause injury and even death to the developing fetus, when used during the second and third trimester of pregnancy.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight, light-resistant container as defines in the USP using a child-resistant closure.
Keep container tightly closed.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
When pregnancy is detected, Olmesartan should be discontinued as soon as possible, as it can cause injury and even death to the developing fetus, when used during the second and third trimester of pregnancy.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
Olmesartan Medoxomil Tablets USP 20mg Technical Specification:
| Product Name: | Olmesartan Medoxomil Tablets USP |
| Brand Name: | Generic |
| Strength: | (5mg), (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: | Antihypertensive |
| Indication: | Olmesartan is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Olmesartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so that blood can flow more easily. |
| Storage: | Store at 20° to 25°C (68° to 77°F). Store in dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Olmesartan Medoxomil Tablets USP 5mg
- Olmesartan Medoxomil Tablets USP 20mg
- Olmesartan Medoxomil Tablets USP 40mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Olmesartan Medoxomil Tablets USP 5mg
Each film-coated tablet contains:
Olmesartan Medoxomil USP 5mg
Excipients q.s
Color: Sunset yellow FCF - Olmesartan Medoxomil Tablets USP 20mg
Each film-coated tablet contains:
Olmesartan Medoxomil USP 20mg
Excipients q.s
Color: Ponceau 4R - Olmesartan Medoxomil Tablets USP 40mg
Each film-coated tablet contains:
Olmesartan Medoxomil USP 40mg
Excipients q.s
Color: Ponceau 2R
THERAPEUTIC INDICATIONS:
Olmesartan is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Olmesartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so that blood can flow more easily.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight, light-resistant container as defines in the USP using a child-resistant closure.
Keep the container tightly closed.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
When pregnancy is detected, Olmesartan should be discontinued as soon as possible, as it can cause injury and even death to the developing fetus, when used during the second and third trimesters of pregnancy.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
