SPL v2
SPL
SPL Set ID f6e923e8-46e8-4287-bd62-5b954829cd73
Route
ORAL
Published
Effective Date 2011-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg) Sennosides A And B (8.6 mg)
Inactive Ingredients
Carnauba Wax Colloidal Silicon Dioxide Croscarmellose Sodium D&c Yellow No. 10 Dibasic Calcium Phosphate Dihydrate Fd&c Yellow No. 6 Hypromellose 2910 (6 Mpa.s) Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol Sodium Benzoate Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL081 Shape: round Color: orange Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-03-16

Description

Active ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg


Medication Information

Warnings and Precautions

Do not use if your are taking mineral oil; 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

children under 2 years - ask a doctor

Description

Active ingredients (in each tablet) Docusate sodium 50 mg 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.

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 50567-7

Directions take preferably at bedtime or as directed by a doctor

If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maxiumum dosage)







Section 50568-5

Ask a doctor or pharmacist berfore use if you are taking any other drug.  Laxatives may affect how other drugs work.

Section 50569-3

ASK A DOCTOR BEFORE USE IF YOU HAVE A SUDDEN CHANGE IN BOWEL HABITS THAT LASTS OVER TWO WEEKS

Section 51727-6

  Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium

D-C yellow #10 aluminum lake, dibasic calcium phosphate

dihydrate, FD-C yellow #6 aluminum lake, hypromellose,

magnesium stearate, microcrystalline cellulose, polyethylene

glycol, sodium benzoate, stearic acide, Titanium dioxide

Section 51945-4

Enter section text here

Section 53413-1

call 1 800 645-2158 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; generally produces bowel movement in  6-12 hours.

Section 55106-9

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg


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

children under 2 years - ask a doctor

Warnings and Precautions (34071-1)

Do not use if your are taking mineral oil; 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 50567-7 (50567-7)

Directions take preferably at bedtime or as directed by a doctor

If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maxiumum dosage)







Section 50568-5 (50568-5)

Ask a doctor or pharmacist berfore use if you are taking any other drug.  Laxatives may affect how other drugs work.

Section 50569-3 (50569-3)

ASK A DOCTOR BEFORE USE IF YOU HAVE A SUDDEN CHANGE IN BOWEL HABITS THAT LASTS OVER TWO WEEKS

Section 51727-6 (51727-6)

  Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium

D-C yellow #10 aluminum lake, dibasic calcium phosphate

dihydrate, FD-C yellow #6 aluminum lake, hypromellose,

magnesium stearate, microcrystalline cellulose, polyethylene

glycol, sodium benzoate, stearic acide, Titanium dioxide

Section 51945-4 (51945-4)

Enter section text here

Section 53413-1 (53413-1)

call 1 800 645-2158 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; generally produces bowel movement in  6-12 hours.

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)