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

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

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

Medication Information

Warnings

Active Ingredient

Sennosides 8.6mg

Uses

relieves occasional constipation (irregularity)
this product generally produces a bowel movement in 6 to 12 hours

Purpose

Laxative

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

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

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

Questions?

Adverse drug event call: (866) 562-2756

Section 51945-4

Do Not Use

for more than one week unless directed by a doctor

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)

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.

Structured Label Content

Warnings

Active Ingredient (Active ingredient (in each tablet))

Sennosides 8.6mg

Uses

relieves occasional constipation (irregularity)
this product generally produces a bowel movement in 6 to 12 hours

Purpose

Laxative

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

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

Questions?

Adverse drug event call: (866) 562-2756

Section 51945-4 (51945-4)

Do Not Use (Do not use)

for more than one week unless directed by a doctor

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)

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.

Advanced Ingredient Data

[{"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "L11K75P92J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SENNOSIDES A AND B", "unii": "1B5FPI42EN", "classCode": "ACTIB", "strengthNumerator": "8.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves occasional constipation (irregularity) this product generally produces a bowel movement in 6 to 12 hours", "Purpose": "Laxative", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:09.458675 · Updated: 2026-03-14T23:08:47.595357