209r Rite Aid 11822 3702 1 Laxative Stool Softener/stimulant Laxative 400 Count

209r Rite Aid 11822 3702 1 Laxative Stool Softener/stimulant Laxative 400 Count
SPL v2
SPL
SPL Set ID addc108a-ea97-9c87-e053-2995a90acbe4
Route
ORAL
Published
Effective Date 2020-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: TCL097 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-01

Description

Active ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

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

Indications and Usage (34067-9)

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 years: ask a doctor

Warnings and Precautions (34071-1)

Warnings

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 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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