Chemical Auxiliary

GMP certified high quality DIclofenac sodium USP BP 50mg 100mg tablet

?

Compostion:

Each plain tablet contains diclofenac sodium 50mg.

?

Description:

Yellow plain caplet, the length of the tablet is about 21mm.

?

Specificaiton:

25mg, 50mg or 100mg /tablet.

Package:

10 tablets/blister, 10 blisters/box.

?

Indications:

1. Acute and chronic rheumatoid arthritis, acute and chronic ankylosing spondylitis, osteoarthritis.
2. Shoulder, bursitis, tendonitis and tenosynovitis.
3. Low back pain, sprains, strain and other soft tissue injuries.
4. Acute gout.
5. Dysmenorrhea or uterine annex inflammation, pain and postoperative pain.
6. Post-traumatic pain and inflammation, such as sprains, muscle strain and so on;
7. ENT severe infection pain and inflammation (such as tonsillitis, otitis, sinusitis, etc.), should also use anti-infective drugs.

?

Side effects:

Diclofenac side effects
Get emergency medical help if you have signs of an allergic reaction to diclofenac: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.
Stop using diclofenac and call your doctor at once if you have:
the first sign of any skin rash, no matter how mild;
shortness of breath (even with mild exertion);
swelling or rapid weight gain;
signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
high blood pressure - severe headache, pounding in your neck or ears, nosebleed, anxiety, confusion;
low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common diclofenac side effects may include:
indigestion, gas, stomach pain, nausea, vomiting;
diarrhea, constipation;
headache, dizziness, drowsiness;
stuffy nose;
itching, increased sweating;
increased blood pressure; or
swelling or pain in your arms or legs.

?

Storage:
Store in a cool, dry place.
Keep out of reach of children.

?

Sheft time:

3years.

?

Certificate of Analysis?

- - - -
Name of Drug | Diclofenac sodium Tablets | Batch No. | 120201 |
Mfg. Date: | 02/2012 | Exp. Date | 01/2015 |
Sampling date | 15/02/2012 | Report date? | 22/02/2012 |
Specification | 10tabs/strip, 10strips/box, 10boxes/shrink, 20shrinks/carton | Quantity | 170cartons |
Standards: | BP2005 | ? | ? |

- - - -
ITemS | Standards | Results |
Characteristics: | Yellowish caplet | Complies |
Identification: | Should Positive reaction | Complies |
Uniformity of dosage units: | ≤±5.0% | ±4.0% |
Average content: | Meets the requirements | Complies |
Friability of tablet: | Meets the requirements | Complies |
Disintegrated time | Not less than 15 minutes | 7 minutes |
Microbial Contamination: | Meets the requirements | Complies |
Assay | C14H10Cl2NNaO2: 95.0%~105.0% ? | 99.8% ? |
- - - -
|
- - - -

?



?

?

?

?

?

?

?

?

?

?