371 - senna laxative

SPL v1

SPL

SPL Set ID 9393032e-4343-4ac5-8e91-36013e5ca089

Route

oral

Published

Effective Date 2024-06-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

sennosides (8.6 mg)

Inactive Ingredients

croscarmellose sodium dibasic calcium phosphate dihydrate magnesium stearate microcrystalline cellulose silicon dioxide

Identifiers & Packaging

Pill Appearance

Imprint: AZ217 Shape: round Color: brown Size: 8 mm Score: 1

Marketing Status

otc monograph drug active Since 2024-06-18

Purpose

Laxative

Description

Sennosides 8.6mg

Medication Information

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 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

Other Information

each tablet contains: calcium 50mg
store at 20°C-25°C (68°F-77°F); excursions permitted between 15°-30°C (59°-86°F)
do not use if safety seal under cap is broken or missing

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide

Description

Sennosides 8.6mg

Principal Display Panel

Senna Laxative

Use(s)

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

Do Not Use

laxative products for longer than one week unless directed by a doctor

Questions/comments

Call 1-888-952-0050 Monday - Friday 9AM -5PM EST,

Active Ingredient(s)

Sennosides 8.6mg

Ask A Doctor Before Use If

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 could be signs of a serious condition.

If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

Structured Label Content

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 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

Other Information (Other information)

each tablet contains: calcium 50mg
store at 20°C-25°C (68°F-77°F); excursions permitted between 15°-30°C (59°-86°F)
do not use if safety seal under cap is broken or missing

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide

Principal Display Panel

Senna Laxative

Use(s)

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

Do Not Use (Do not use)

laxative products for longer than one week unless directed by a doctor

Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday - Friday 9AM -5PM EST,

Active Ingredient(s) (Active ingredient(s))

Sennosides 8.6mg

Ask A Doctor Before Use If (Ask a doctor before use if)

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 (Stop use and ask a doctor if)

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

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

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

Advanced Ingredient Data

[{"name": "SENNOSIDES", "unii": "3FYP5M0IJX", "classCode": "ACTIB", "strengthNumerator": "8.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use(s)": "relieves occasional constipation (irregularity) generally produces a bowel movement in 6-12 hours", "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 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": "laxative products for longer than one week unless directed by a doctor", "Other information": "each tablet contains: calcium 50mg store at 20°C-25°C (68°F-77°F); excursions permitted between 15°-30°C (59°-86°F) do not use if safety seal under cap is broken or missing", "Questions/Comments": "Call 1-888-952-0050 Monday - Friday 9AM -5PM EST,", "Active ingredient(s)": "Sennosides 8.6mg", "Inactive ingredients": "croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide", "Principal Display Panel": "Senna Laxative", "Ask a doctor before use if": "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 could be signs of a serious condition.", "If pregnant or breastfeeding,": "ask a health professional before use.", "Keep out of reach of children": "In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:10.386234 · Updated: 2026-03-14T23:03:06.131630