192r - Target -doc Sod 50 Mg & Sennosides 8.6 Mg

192r - Target -doc Sod 50 Mg & Sennosides 8.6 Mg
SPL v2
SPL
SPL Set ID 7c74bd91-6687-2b89-e053-2a91aa0ad6b8
Route
ORAL
Published
Effective Date 2019-03-29
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
Sodium Benzoate Titanium Dioxide Hypromelloses Magnesium Stearate Microcrystalline Cellulose Carnauba Wax Silicon Dioxide Dibasic Calcium Phosphate Dihydrate D&c Yellow No. 10 Food Yellow 3 Free Acid Polyethylene Glycol, Unspecified Stearic Acid Croscarmellose

Identifiers & Packaging

Pill Appearance
Imprint: TCL081 Shape: round Color: orange Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-03-29

Description

Each Tablet contains: Docusate sodium 50 mg Sennosides 8.6 mg

Indications and Usage

Relieves occasional constipation (irregularity); generally causes a bowel movement in 6-12 hours

Purpose

Stimulant Laxative and Stool Softener

Dosage and Administration

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 (not to exceed maximum dosage) or decrease dose until you are comfortable. Adults and children 12 years and older: - Starting dosage: 2 tablets once a day - Maximum dosage: 4 tablets twice a day Children 6 to under 12 years: - Starting dosage: 1 tablet once a day-Maximum dosage: 2 tablets twice a day Children 2 to under 6 years - Starting dosage: 1/2 tablet once a day- Maximum dosage: 1 tablet twice a day Children under 2 years - Ask a doctor


Medication Information

Indications and Usage

Relieves occasional constipation (irregularity); generally causes a bowel movement in 6-12 hours

Purpose

Stimulant Laxative and Stool Softener

Dosage and Administration

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 (not to exceed maximum dosage) or decrease dose until you are comfortable.

Adults and children 12 years and older: - Starting dosage: 2 tablets once a day - Maximum dosage: 4 tablets twice a day

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

Children 2 to under 6 years - Starting dosage: 1/2 tablet once a day- Maximum dosage: 1 tablet twice a day

Children under 2 years - Ask a doctor

Description

Each Tablet contains: Docusate sodium 50 mg Sennosides 8.6 mg

Section 51945-4

Warnings

WARNINGS:

Do not use this product



If you are presently taking mineral oil unless directed by a doctor



Laxative products for longer than 1 week unless directed by a doctor

Active Ingredients

Each Tablet contains:

Docusate sodium 50 mg

Sennosides 8.6 mg

Inactive Ingredients
INACTIVE INGREDIENTS: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, d-c yellow#10 aluminum lake, fd&c yellow#6 aluminum lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

Pregnant Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.

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


Structured Label Content

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Stimulant Laxative and Stool Softener

Warnings (WARNINGS)

WARNINGS:

Do not use this product



If you are presently taking mineral oil unless directed by a doctor



Laxative products for longer than 1 week unless directed by a doctor

Active Ingredients (ACTIVE INGREDIENTS)

Each Tablet contains:

Docusate sodium 50 mg

Sennosides 8.6 mg

Inactive Ingredients (INACTIVE INGREDIENTS)
INACTIVE INGREDIENTS: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, d-c yellow#10 aluminum lake, fd&c yellow#6 aluminum lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

Indications and Usage (INDICATIONS AND USAGE)

Relieves occasional constipation (irregularity); generally causes a bowel movement in 6-12 hours

Dosage and Administration (DOSAGE AND ADMINISTRATION)

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 (not to exceed maximum dosage) or decrease dose until you are comfortable.

Adults and children 12 years and older: - Starting dosage: 2 tablets once a day - Maximum dosage: 4 tablets twice a day

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

Children 2 to under 6 years - Starting dosage: 1/2 tablet once a day- Maximum dosage: 1 tablet twice a day

Children under 2 years - Ask a doctor

Pregnant Or Breast Feeding (PREGNANT OR BREAST FEEDING)
If pregnant or breastfeeding, ask a health professional before use.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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