Gc 454

Gc 454
SPL v6
SPL
SPL Set ID 7aa66bf1-d765-adce-e053-2991aa0a93a3
Route
ORAL
Published
Effective Date 2018-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg)
Inactive Ingredients
Silicon Dioxide Cellulose, Microcrystalline Croscarmellose Sodium Calcium Phosphate, Dibasic, Anhydrous Magnesium Silicate Magnesium Stearate Mineral Oil Polyethylene Glycol, Unspecified Hypromelloses Carnauba Wax

Identifiers & Packaging

Pill Appearance
Imprint: AZ217 Shape: round Color: brown Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-04-01 Until 2027-03-31
Description

Sennosides 8.6 mg

Purpose

Laxative

Medication Information

Purpose

Laxative

Description

Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Warnings

Do not use

for more than 1 week unless directed by a doctor.

Ask a doctor before use if you

  • have abdominal pain, nausea or vomiting
  • have noticed a sudden change in bowel habits that lasts over 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 may indicate a serious condition .

If pregnant or breast-feeding,

ask a health professional before use.

Directions

• do not exceed 8 tablets in 24 hours

Age

Starting Dose

Maximum Dose

adults and children 12 years of age and older

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

4 tablets in the morning and 4 tablets at bedtime

children under 12 years

ask a doctor





Package Label

Other Information
  • each tablet contains: calcium 40 mg
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
  • store at room temperature
Inactive Ingredients

cellulose, croscarmellose sodium,

dicalcium phosphate, hypromellose*, magnesium silicate*,

magnesium stearate, mineral oil*, PEG*, silica*, wax*.

*May contain these ingredients

Active Ingredient (in Each Tablet)

Sennosides 8.6 mg

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Purpose

Laxative

Warnings

Do not use

for more than 1 week unless directed by a doctor.

Ask a doctor before use if you

  • have abdominal pain, nausea or vomiting
  • have noticed a sudden change in bowel habits that lasts over 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 may indicate a serious condition .

If pregnant or breast-feeding,

ask a health professional before use.

Directions

• do not exceed 8 tablets in 24 hours

Age

Starting Dose

Maximum Dose

adults and children 12 years of age and older

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

4 tablets in the morning and 4 tablets at bedtime

children under 12 years

ask a doctor





Package Label

Other Information (Other information)
  • each tablet contains: calcium 40 mg
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

cellulose, croscarmellose sodium,

dicalcium phosphate, hypromellose*, magnesium silicate*,

magnesium stearate, mineral oil*, PEG*, silica*, wax*.

*May contain these ingredients

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Sennosides 8.6 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:28.221676 · Updated: 2026-03-14T23:10:57.415546