SPL v1
SPL
SPL Set ID d5683aba-5292-4a36-9ba7-52d322779111
Route
ORAL
Published
Effective Date 2019-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 1122 Shape: round Color: brown Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-01-09

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 no bowel movement  within 12 hours

• you have rectal bleeding 

These could be signs of 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

Label Image for 53808-1110

8.6mg

Other Information

each tablet contains: calcium 20 mg

• store at room temperature

This Product was Repackaged By:

DOH CENTRAL PHARMACY

104 HAMILTON PARK DR # 2

TALLAHASSEE, FL 32304

USA

Inactive Ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG.

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 no bowel movement  within 12 hours

• you have rectal bleeding 

These could be signs of 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 (PACKAGE LABEL)

Label Image for 53808-1110

8.6mg

Other Information (Other information)

each tablet contains: calcium 20 mg

• store at room temperature

This Product was Repackaged By:

DOH CENTRAL PHARMACY

104 HAMILTON PARK DR # 2

TALLAHASSEE, FL 32304

USA

Inactive Ingredients (Inactive ingredients)

cellulose, croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG.

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

Sennosides 8.6 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)