Senna-s Tablets

Senna-s Tablets
SPL v1
SPL
SPL Set ID 727b02f3-bcd1-4568-9a0d-7723b6264800
Route
ORAL
Published
Effective Date 2010-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg) Sennosides (8.6 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromellose Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol Sodium Benzoate Stearic Acid Starch, Tapioca Tartaric Acid Titanium Dioxide Aluminum Oxide

Identifiers & Packaging

Pill Appearance
Imprint: 8 Shape: round Color: yellow Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-08-17

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Purpose

Stool softener & Stimulant laxative


Medication Information

Purpose

Stool softener & Stimulant laxative

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally causes a bowel movement in 6 to 12 hours
Directions
  • take preferably at bedtime or as directed by a doctor
  • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage); or decrease dose until you are comfortable
  • age starting dose maximum dose
    adults and children 12 years and over 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
  • this product if you are presently taking mineral oil, unless directed by a doctor
  • laxative products for more than 1 week unless directed by a doctor
Package Label
Other Information
  • each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM)
  • TAMPER-EVIDENT: Do not use this product if foil seal on back of blister is cut, torn, broken or missing
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, tapioca starch1, tartaric acid1, titanium dioxide

1 may contain these ingredients

Questions Or Comments?

call 1-888-838-2872, weekdays, 8 AM-5 PM Eastern Time

Distributed by:

GOLDLINE LABORATORIES, INC.

Sellersville, PA 18960 Dist. 1999 0110REV 89

192B R1009

Repackaged by:



Contract Pharmacy Services-PA

125 Titus Ave Suite 200

Warrington, PA 18976 USA

Original--08/2010--NJW

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that persists over 2 weeks
Stop Use and Ask A Doctor If You Have
  • have rectal bleeding
  • fail to have a bowel movement after the use of a laxative

These could be signs of a serious condition


Structured Label Content

Uses (USES)
  • relieves occasional constipation (irregularity)
  • generally causes a bowel movement in 6 to 12 hours
Purpose (PURPOSE)

Stool softener & Stimulant laxative

Directions (DIRECTIONS)
  • take preferably at bedtime or as directed by a doctor
  • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage); or decrease dose until you are comfortable
  • age starting dose maximum dose
    adults and children 12 years and over 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)
  • this product if you are presently taking mineral oil, unless directed by a doctor
  • laxative products for more than 1 week unless directed by a doctor
Package Label
Other Information (OTHER INFORMATION)
  • each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM)
  • TAMPER-EVIDENT: Do not use this product if foil seal on back of blister is cut, torn, broken or missing
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients (INACTIVE INGREDIENTS)

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, tapioca starch1, tartaric acid1, titanium dioxide

1 may contain these ingredients

Questions Or Comments? (QUESTIONS OR COMMENTS?)

call 1-888-838-2872, weekdays, 8 AM-5 PM Eastern Time

Distributed by:

GOLDLINE LABORATORIES, INC.

Sellersville, PA 18960 Dist. 1999 0110REV 89

192B R1009

Repackaged by:



Contract Pharmacy Services-PA

125 Titus Ave Suite 200

Warrington, PA 18976 USA

Original--08/2010--NJW

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (IN EACH TABLET))

Docusate sodium 50 mg

Sennosides 8.6 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that persists over 2 weeks
Stop Use and Ask A Doctor If You Have (Stop use and ask a doctor if you have)
  • have rectal bleeding
  • fail to have a bowel movement after the use of a laxative

These could be signs of a serious condition


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)