Heb 209r Sennosides 8.6mg / Docusate Sodium 50mg 240ct

Heb 209r Sennosides 8.6mg / Docusate Sodium 50mg 240ct
SPL v3
SPL
SPL Set ID c19280c2-f968-b582-e053-2995a90a9bd3
Route
ORAL
Published
Effective Date 2025-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg) Sennosides (8.6 mg)
Inactive Ingredients
Silicon Dioxide Hypromelloses Magnesium Stearate Polyethylene Glycol, Unspecified Carnauba Wax Titanium Dioxide Sodium Benzoate Microcrystalline Cellulose Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Red No. 40 Aluminum Lake Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: TCL097 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-04

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Dosage and Administration

Directions

  • take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

adults and children

12 years and older

take 2-4 tablets daily

children 6 to

under 12 years of age

take 1-2 tablets daily

children 2 to

under 6 years of age

take up to 1 tablet daily

children under 2

ask a doctor

Description

Drug Facts

Uses

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

Section 50569-3

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks
Section 50570-1

Do not use

  • laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil unless told to do so by a doctor
Section 51727-6

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

Section 51945-4

Section 53413-1

Questions or comments call 1-877-290-4008

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purposes

Stool Softener

Stimulant laxative

Section 55106-9

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Section 60561-8

Other information

  • each tablet contains: calcium 20 mg, sodium 6 mg (VERY LOW SODIUM)
  • Store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

Structured Label Content

Uses (USES)

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
Dosage and Administration (34068-7)

Directions

  • take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

adults and children

12 years and older

take 2-4 tablets daily

children 6 to

under 12 years of age

take 1-2 tablets daily

children 2 to

under 6 years of age

take up to 1 tablet daily

children under 2

ask a doctor

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

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 (1-800-222-1222).

Section 50566-9 (50566-9)

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks
Section 50570-1 (50570-1)

Do not use

  • laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil unless told to do so by a doctor
Section 51727-6 (51727-6)

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments call 1-877-290-4008

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purposes

Stool Softener

Stimulant laxative

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Section 60561-8 (60561-8)

Other information

  • each tablet contains: calcium 20 mg, sodium 6 mg (VERY LOW SODIUM)
  • Store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

Advanced Ingredient Data


Raw Label Data

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