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

Drug Facts

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

Description

Sennosides

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

Sennosides

Uses

For relief of occasional constipation and irregularity.

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

Section 51945-4

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.

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.


Structured Label Content

Uses

For relief of occasional constipation and irregularity.

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

Section 51945-4 (51945-4)

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 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.

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 (Keep out of Reach of Children)

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


Advanced Ingredient Data


Raw Label Data

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