195r Leader-cardinal 24 Count Blisters 70000-0077-1

195r Leader-cardinal 24 Count Blisters 70000-0077-1
SPL v3
SPL
SPL Set ID b7b13bfa-8a94-6f62-e053-2995a90abbf4
Route
ORAL
Published
Effective Date 2019-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (25 mg)
Inactive Ingredients
Croscarmellose Ferrous Oxide Fd&c Blue No. 1 Ferric Oxide Yellow Magnesium Stearate Polyethylene Glycol, Unspecified Povidone Dibasic Calcium Phosphate Dihydrate Kaolin Raw Sugar Acacia Ferrosoferric Oxide Stearic Acid Maltodextrin Carnauba Wax Starch, Corn Calcium Cation Silicon Dioxide Microcrystalline Cellulose Shellac Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL083 Shape: round Color: blue Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-11

Description

Each Tablet contains: SENNOSIDES,USP 25 mg


Medication Information

Warnings and Precautions

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

Indications and Usage

INDICATIONS & USAGE

Uses:

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

Dosage and Administration

Directions:

Swallow tablet(s) with a glass of water

Swallow tablet(s) whole do not crush, break, or chew

Adults and children 12years of age and older

Take 2 tablets once or twice daily

Children 6 to under 12 years of age

Take 1 tablet once or twice daily

children under 6 years of age

ask a doctor

Description

Each Tablet contains: SENNOSIDES,USP 25 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 51945-4

Section 55105-1

PURPOSE:

Stimulant Laxative

Active Ingredient

Each Tablet contains:

SENNOSIDES,USP 25 mg

Inactive Ingredients

INACTIVE INGREDIENTS: acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#1, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide


Structured Label Content

Indications and Usage (34067-9)

INDICATIONS & USAGE

Uses:

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

Dosage and Administration (34068-7)

Directions:

Swallow tablet(s) with a glass of water

Swallow tablet(s) whole do not crush, break, or chew

Adults and children 12years of age and older

Take 2 tablets once or twice daily

Children 6 to under 12 years of age

Take 1 tablet once or twice daily

children under 6 years of age

ask a doctor

Warnings and Precautions (34071-1)

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

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 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE:

Stimulant Laxative

Active Ingredient (ACTIVE INGREDIENT)

Each Tablet contains:

SENNOSIDES,USP 25 mg

Inactive Ingredients (INACTIVE INGREDIENTS)

INACTIVE INGREDIENTS: acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#1, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide


Advanced Ingredient Data


Raw Label Data

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