SPL v1
SPL
SPL Set ID 718c3ca4-cb95-432e-e053-2a95a90a8130
Route
ORAL
Published
Effective Date 2018-01-01
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 Dibasic Calcium Phosphate Dihydrate Hypromellose 2910 (6 Mpa.s) Magnesium Stearate Cellulose, Microcrystalline Mineral Oil

Identifiers & Packaging

Pill Appearance
Imprint: TCL080 Shape: round Color: brown Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2006-02-09

Description

Active ingredient (in each tablet) Sennosides 8.6mg


Medication Information

Warnings and Precautions

Do not use for longer than one week, when abdominal pain, nausea or vomiting are present.

Indications and Usage

Relieves occasional constipation

Generally produces bowel movement in 6-12 hours

Dosage and Administration

Dosage and Administration

Adults and children 12 years and over - 2 tablets once a day - maximum dosage - 4 tablets twice a day

Children 6 to under 12 years - 1 tablet once a day maximum dosage - 2 tablets twice a day

children 2 to under 6 years - 1/2 tablet once a day - maximum dosage - 1 tablet twice a day

Description

Active ingredient (in each tablet) Sennosides 8.6mg

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if: you have rectal bleeding; you fail to have a bowel movement after use of this product.  These may indicate a serious condition.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking any other drug.  Take this product tow or more hours before or after other drugs.  Laxatives may affect how other drugs work.

Section 50569-3

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks.

Section 51727-6

Inactive Ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, minerol  oil

Section 51945-4

Section 53413-1

1800 645-2158 9 am - 5 pm Monday - Friday

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

uses

relieves occasional constipation(irregularity);generally causes bowel movement in 6-12 hours.

Section 55106-9

Active ingredient (in each tablet) Sennosides 8.6mg


Structured Label Content

Indications and Usage (34067-9)

Relieves occasional constipation

Generally produces bowel movement in 6-12 hours

Dosage and Administration (34068-7)

Dosage and Administration

Adults and children 12 years and over - 2 tablets once a day - maximum dosage - 4 tablets twice a day

Children 6 to under 12 years - 1 tablet once a day maximum dosage - 2 tablets twice a day

children 2 to under 6 years - 1/2 tablet once a day - maximum dosage - 1 tablet twice a day

Warnings and Precautions (34071-1)

Do not use for longer than one week, when abdominal pain, nausea or vomiting are present.

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if: you have rectal bleeding; you fail to have a bowel movement after use of this product.  These may indicate a serious condition.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking any other drug.  Take this product tow or more hours before or after other drugs.  Laxatives may affect how other drugs work.

Section 50569-3 (50569-3)

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks.

Section 51727-6 (51727-6)

Inactive Ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, minerol  oil

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1800 645-2158 9 am - 5 pm Monday - Friday

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

uses

relieves occasional constipation(irregularity);generally causes bowel movement in 6-12 hours.

Section 55106-9 (55106-9)

Active ingredient (in each tablet) Sennosides 8.6mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)