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SENNA

HIMPRIT PHARMACHEM PVT LTD
SPIRIT PHARMACEUTICALS,LLC

SENNA TABLETS 8.6 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

SENNA Uses

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6-12 hours

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medial help or contact a Poison Control Center right away.

Directions

  • take preferably at bedtime or as directed by a doctor
age starting dosage maximum dosage
adults and children 12 years of age or older 2 tablets once a day 4 tablets twice a day
children 6 to under 12 years 1 tablet once a day 2 tablets twice a day
children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day
children under 2 years ask a doctor ask a doctor

SENNA Other information

  • each tablet contains: calcium 25mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

PRINCIPAL DISPLAY PANEL - Shipping Label

Each Film Coated Tablet Contains :
CALCIUM SENNOSIDES 8.6mg

Lot No. :
Mfg. Date :
Exp. Date :
Jar No. :
Quantity : 50,000 Tablets
NDC No : 65437 - 087 - 50

WARNING :
KEEP OUT OF THE REACH OF CHILDREN

STORE AT CONTROLLED ROOM TEMPERATURE OF 59°-77°F (15°-25° C )
PROTECT FROM LIGHT, MOISTURE AND FREEZING.

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDER.

Manufactured By :
MANUFACTURER CODE No.: Guj/Drugs/G/1362
LABELER CODE # 14803

Manufactured For.
HIMPRIT PHARMACHEM PVT. LTD.
"LAKULESH", R.V. DESAI ROAD,
NEXT TO NAVAPURA POLICE STATION,
BARODA, INDIA - 390 001

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

SENNA

SENNA

SENNA TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65437-087
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SENNA SENNA 8.6 mg

Inactive Ingredients

Ingredient Name Strength
maltodextrin
cellulose, microcrystalline
CROSCARMELLOSE SODIUM
STEARIC ACID
SILICON DIOXIDE
MAGNESIUM STEARATE
hypromellose
Mineral Oil
water

Product Characteristics

Color Size Imprint Code Shape
BROWN 10 mm S8 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50000 in 1 BAG
2 NDC:65437-087-50 1 in 1 DRUM

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2009-11-20


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Be sure to consult your doctor before taking any medication!
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