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Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg) Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg) Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg) Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg) Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg) Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg) Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
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Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg) Technical Specification:

Product Name:Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP
Brand Name:Noforge
Strength:(5mg+160mg+12.5mg), (10mg+160mg+12.5mg), (10mg+160mg+25mg), (10mg+320mg+25mg)
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: Amlodipine, valsartan, and hydrochlorothiazide is a combination of medicines that is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.
Storage:Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Store in dry place protected from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  1. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+12.5mg)
  2. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
  3. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
  4. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+320mg+25mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1.Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+12.5mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine………………..5mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP…………………..12.5mg
Excipients………………………………………q.s
Color: Sunset yellow FCF

2.Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP……………………12.5mg
Excipients………………………………………………q.s
Color: Orange G

3.Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP……………………25mg
Excipients………………………………………………q.s
Color: Ponceau 4 R

4.Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+320mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………..320mg
Hydrochlorothiazide USP……………………25mg
Excipients………………………………………………q.s
Color: Ponceau 2 R

THERAPEUTIC INDICATIONS:

Amlodipine, valsartan, and hydrochlorothiazide is a combination of medicines that is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. 

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 container with a child-resistant closure.

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) ; excursions permitted between 15°C to 30°C (59°F to 86°F).

Store in dry place protected from light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end county.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+12.5mg)
B. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
C. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
D. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+320mg+25mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+12.5mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine………………..5mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP…………………..12.5mg
Excipients………………………………………q.s
Color: Sunset yellow FCF

B. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP……………………12.5mg
Excipients………………………………………………q.s
Color: Orange G

C. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP……………………25mg
Excipients………………………………………………q.s
Excipients………………………………………………….q.s
Color: Ponceau 4 R

D. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+320mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………...320mg
Hydrochlorothiazide USP……………………25mg
Excipients………………………………………………q.s
Color: Ponceau 2 R

THERAPEUTIC INDICATIONS:

Amlodipine, valsartan, and hydrochlorothiazide is a combination of medicines that is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.

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 container with a child-resistant closure.
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); excursions permitted between 15°C to 30°C (59°F to 86°F).
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.