Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa
Route
ORAL
Published
Effective Date 2012-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides A And B (8.6 mg)
Inactive Ingredients
Croscarmellose Sodium Calcium Phosphate, Dibasic, Anhydrous Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Mineral Oil

Identifiers & Packaging

Pill Appearance
Imprint: S8 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-01-24

Description

Sennosides 8.6mg

Purpose

Laxative

How Supplied

Senna Laxative Tablets are available as follows: 8.6 mg: Brown, round, scored tablet, debossed “SB”. Available in bottles of 10 tablets (NDC 43063-838-10) 30 tablets (NDC 43063-838-30)


Medication Information

Purpose

Laxative

How Supplied

Senna Laxative Tablets are available as follows: 8.6 mg: Brown, round, scored tablet, debossed “SB”. Available in bottles of 10 tablets (NDC 43063-838-10) 30 tablets (NDC 43063-838-30)

Description

Sennosides 8.6mg

Uses
  • relieves occasional constipation (irregularity)

  • this product generally produces a bowel movement in 6 to 12 hours

Section 51945-4
Warnings


Directions
  • do not exceed recommended dose
Age

Starting Dose

Maximum Dose

adults and children 12 years of age and older

2 tablets once a day preferably at bedtime; increase if needed, or as directed by a doctor

4 tablets twice a day, in the morning and at bedtime

children under 12 years

ask a doctor

ask a doctor

Do Not Use

for more than one week unless directed by a doctor

Questions?

Adverse drug event call: (866) 562-2756

16 How Supplied

Senna Laxative Tablets are available as follows:

8.6 mg: Brown, round, scored tablet, debossed “SB”. Available in bottles of

10 tablets (NDC 43063-838-10)

30 tablets (NDC 43063-838-30)

Other Information
  • Tamper Evident: Do not use if safety seal is broken or missing from bottle.
  • each tablet contains: calcium 20 mg, potassium 70 mg

  • store at room temperature 

Inactive Ingredients:

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

Stop Use and Ask A Doctor If
  • you have no bowel movement within 12 hours
  • you have rectal bleeding

These could be signs of a serious condition

Ask A Doctor Before Use If You
  • have abdominal pain, nausea, or vomiting
  • are taking mineral oil
  • noticed a sudden change in bowel habits that last over 2 weeks
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)

Sennosides 8.6mg


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)

  • this product generally produces a bowel movement in 6 to 12 hours

Section 51945-4 (51945-4)
Purpose

Laxative

Warnings


Directions
  • do not exceed recommended dose
Age

Starting Dose

Maximum Dose

adults and children 12 years of age and older

2 tablets once a day preferably at bedtime; increase if needed, or as directed by a doctor

4 tablets twice a day, in the morning and at bedtime

children under 12 years

ask a doctor

ask a doctor

Do Not Use (Do not use)

for more than one week unless directed by a doctor

Questions?

Adverse drug event call: (866) 562-2756

16 How Supplied (16 HOW SUPPLIED)

Senna Laxative Tablets are available as follows:

8.6 mg: Brown, round, scored tablet, debossed “SB”. Available in bottles of

10 tablets (NDC 43063-838-10)

30 tablets (NDC 43063-838-30)

Other Information (Other information)
  • Tamper Evident: Do not use if safety seal is broken or missing from bottle.
  • each tablet contains: calcium 20 mg, potassium 70 mg

  • store at room temperature 

Inactive Ingredients: (Inactive ingredients:)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have no bowel movement within 12 hours
  • you have rectal bleeding

These could be signs of a serious condition

Ask A Doctor Before Use If You (Ask a doctor before use if you)
  • have abdominal pain, nausea, or vomiting
  • are taking mineral oil
  • noticed a sudden change in bowel habits that last over 2 weeks
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))

Sennosides 8.6mg


Advanced Ingredient Data


Raw Label Data

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