Senna Tablets 8.6 Mg

Senna Tablets 8.6 Mg
SPL v2
SPL
SPL Set ID ea14be82-1d4d-41fe-9e2f-3f4df9393be5
Route
ORAL
Published
Effective Date 2009-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Senna (8.6 mg)
Inactive Ingredients
Maltodextrin Cellulose, Microcrystalline Croscarmellose Sodium Stearic Acid Silicon Dioxide Magnesium Stearate Hypromellose Mineral Oil Water

Identifiers & Packaging

Pill Appearance
Imprint: S8 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-11-20

Description

Drug Facts

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

Drug Facts

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6-12 hours
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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.

Section 53414-9

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

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
Do Not Use
  • laxative products for longer than 1 week unless directed by a doctor
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

Active Ingredient (in Each Tablet)

Sennosides 8.6 mg

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
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"


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6-12 hours
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.

Section 53414-9 (53414-9)

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

Purpose

Laxative

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
Do Not Use (Do not use)
  • laxative products for longer than 1 week unless directed by a doctor
Other Information (Other information)
  • each tablet contains: calcium 25mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Sennosides 8.6 mg

Ask A Doctor Before Use If You Have (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
Principal Display Panel Shipping Label (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"


Advanced Ingredient Data


Raw Label Data

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