f6e923e8-46e8-4287-bd62-5b954829cd73

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

Active Ingredient

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

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.


Structured Label Content

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

Active Ingredient (55106-9)

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

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

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.


Advanced Ingredient Data


Raw Label Data

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