drug facts

drug facts

SPL v5

SPL

SPL Set ID 61bbbb6a-9997-4df1-94be-a80686d1f1b9

Route

oral

Published

Effective Date 2024-01-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

sennosides a and b (8.6 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: AZ;217 Shape: round Color: brown Size: 8 mm Score: 1

Marketing Status

otc monograph drug active Since 2016-04-18

Purpose

Laxative

Description

Sennosides

Medication Information

Warnings

Do not use laxative products for more than one week unless directed by a doctor

Ask a doctor before use if you have stomach pains, nausea, vomiting, notice a sudden change in bowel habits that continues over a period of 2 weeks.

Stop use and ask a doctor ifrectal bleeding or failure to have a bowel movement occur after use of a laxative. These could be signs of a serious condition.

If Pregnant or breast-feedingask a health professional before use.

Uses

For relief of occasional constipation and irregularity.

This product produces a bowel movement in 6 to 12 hours.

Purpose

Laxative

Directions

Take preferably at bedtime or as directed by a doctor.

Adults and children over 12 years: 2 tablets once a day. Maximum of 4 tablets twice a day.

Children 6 to under 12 years: 1 tablet once a day. Maximum of 2 tablets twice a day.

Children 2 to under 6 years: 1/2 tablet once a day. Maximum of 1 tablet twice a day.

Children under 2: consult a doctor

Inactive Ingredients

croscarmellose sodium, dibasic dicalcium phosphate, magnesium stearate, microcrystalline cellulose, and silicon dioxide.

Description

Sennosides

Section 51945-4

Active Ingredient

Sennosides

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center immediately.

Structured Label Content

Warnings

Do not use laxative products for more than one week unless directed by a doctor

Ask a doctor before use if you have stomach pains, nausea, vomiting, notice a sudden change in bowel habits that continues over a period of 2 weeks.

Stop use and ask a doctor ifrectal bleeding or failure to have a bowel movement occur after use of a laxative. These could be signs of a serious condition.

If Pregnant or breast-feedingask a health professional before use.

Uses

For relief of occasional constipation and irregularity.

This product produces a bowel movement in 6 to 12 hours.

Purpose

Laxative

Directions

Take preferably at bedtime or as directed by a doctor.

Adults and children over 12 years: 2 tablets once a day. Maximum of 4 tablets twice a day.

Children 6 to under 12 years: 1 tablet once a day. Maximum of 2 tablets twice a day.

Children 2 to under 6 years: 1/2 tablet once a day. Maximum of 1 tablet twice a day.

Children under 2: consult a doctor

Inactive Ingredients

croscarmellose sodium, dibasic dicalcium phosphate, magnesium stearate, microcrystalline cellulose, and silicon dioxide.

Section 51945-4 (51945-4)

Active Ingredient

Sennosides

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

In case of accidental overdose, contact a doctor or Poison Control Center immediately.

Advanced Ingredient Data

[{"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "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": "For relief of occasional constipation and irregularity. This product produces a bowel movement in 6 to 12 hours.", "Purpose": "Laxative", "Warnings": "Do not use laxative products for more than one week unless directed by a doctor Ask a doctor before use if you have stomach pains, nausea, vomiting, notice a sudden change in bowel habits that continues over a period of 2 weeks. Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occur after use of a laxative. These could be signs of a serious condition. If Pregnant or breast-feeding ask a health professional before use.", "Directions": "Take preferably at bedtime or as directed by a doctor. Adults and children over 12 years: 2 tablets once a day. Maximum of 4 tablets twice a day. Children 6 to under 12 years: 1 tablet once a day. Maximum of 2 tablets twice a day. Children 2 to under 6 years: 1/2 tablet once a day. Maximum of 1 tablet twice a day. Children under 2: consult a doctor", "Active Ingredient": "Sennosides", "Inactive Ingredients": "croscarmellose sodium, dibasic dicalcium phosphate, magnesium stearate, microcrystalline cellulose, and silicon dioxide.", "Keep out of Reach of Children": "In case of accidental overdose, contact a doctor or Poison Control Center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:51.537712 · Updated: 2026-03-14T23:11:47.306350