d5683aba-5292-4a36-9ba7-52d322779111

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

Purpose

Laxative

Description

Sennosides 8.6 mg


Medication Information

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.

Active Ingredient

Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
Purpose

Laxative

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





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.

Description

Sennosides 8.6 mg

Section 50565-1

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

Package Label

Label Image for 53808-1110

8.6mg


Structured Label Content

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.

Active Ingredient (Active ingredient (in each tablet))

Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
Purpose

Laxative

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





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.

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.

Package Label (PACKAGE LABEL)

Label Image for 53808-1110

8.6mg


Advanced Ingredient Data


Raw Label Data

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