190r Sennosides Tablets Usp 15 Mg Sugar Coated Off-white

190r Sennosides Tablets Usp 15 Mg Sugar Coated Off-white
SPL v3
SPL
SPL Set ID 7498f5fa-1739-bb6e-e053-2a91aa0a5404
Route
ORAL
Published
Effective Date 2025-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides A And B (15 mg)
Inactive Ingredients
Fd&c Red No. 40 Food Yellow 3 Free Acid Kaolin Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Raw Sugar Talc Acacia Povidone Shellac Titanium Dioxide Ferric Oxide Yellow Calcium Cation Carnauba Wax Starch, Corn Croscarmellose Ferrosoferric Oxide Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: TCL079 Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-08-30

Description

Each Tablet contains: Sennosides 15 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

Uses:

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

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 over - 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 6 to under 12 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: Sennosides 15 mg

Section 50565-1

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

Section 51727-6

INACTIVE INGREDIENTS:acacia, calcium sulfate anhydrous, carnauba wax, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#1, FD&C Red#40, FD&C Yellow#6, iron oxide, iron oxide black, iron oxide yellow, Kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol(PEG 400), povidone, Shellac, Sugar, Talc, Titanium dioxide

Section 51945-4

NDC: 49483-079-00

Section 55105-1

stool softner, laxative

Section 55106-9

Each Tablet contains:

Sennosides 15 mg


Structured Label Content

Indications and Usage (34067-9)

Uses:

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

Dosage and Administration (34068-7)

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

Adults and children 12 years and over - 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 6 to under 12 years - starting dosage: 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)

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 the reach of children. Incase of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS:acacia, calcium sulfate anhydrous, carnauba wax, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#1, FD&C Red#40, FD&C Yellow#6, iron oxide, iron oxide black, iron oxide yellow, Kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol(PEG 400), povidone, Shellac, Sugar, Talc, Titanium dioxide

Section 51945-4 (51945-4)

NDC: 49483-079-00

Section 55105-1 (55105-1)

stool softner, laxative

Section 55106-9 (55106-9)

Each Tablet contains:

Sennosides 15 mg


Advanced Ingredient Data


Raw Label Data

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