drug facts

drug facts
SPL v3
SPL
SPL Set ID cd6e3fb4-0c5a-4aa7-89ea-109c6d072efe
Route
oral
Published
Effective Date 2022-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

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

Description

Sennosides 8.6mg

Medication Information

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 under cap is broken or missing
  • each tablet contains: calcium 20 mg, potassium 70 mg

  • store at room temperature 

Description

Sennosides 8.6mg

Questions?

Adverse drug event call: (866) 562-2756

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Section 51945-4

Do Not Use

for more than one week unless directed by a doctor

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

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 under cap is broken or missing
  • each tablet contains: calcium 20 mg, potassium 70 mg

  • store at room temperature 

Questions?

Adverse drug event call: (866) 562-2756

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Section 51945-4 (51945-4)

Do Not Use (Do not use)

for more than one week unless directed by a doctor

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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:04.904322 · Updated: 2026-03-14T23:02:55.861635