Kroger 41226-192-06 (senna-s)

Kroger 41226-192-06 (senna-s)
SPL v3
SPL
SPL Set ID a187045c-c9d6-592a-e053-2995a90adb83
Route
ORAL
Published
Effective Date 2025-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg) Docusate (50 mg)
Inactive Ingredients
Titanium Dioxide Magnesium Stearate Hypromelloses Microcrystalline Cellulose Stearic Acid Sodium Benzoate Dibasic Calcium Phosphate Dihydrate Fd&c Yellow No. 6 Aluminum Lake Croscarmellose Sodium D&c Yellow No. 10 Aluminum Lake Carnauba Wax Silicon Dioxide Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: TCL081 Shape: round Color: orange Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-01

Description

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


Medication Information

Warnings and Precautions

Warnings

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

age

starting dosage

maximum dosage

adults and children 12 years of age and over

2 tablets once a day

4 tablets twice a day

children 6 to under 12

years

1 tablet once a day

2 tablets twice a day

children 2 to under 6

years

½ tablet once a day

1 tablet twice a day

children under 2 years

ask a doctor

ask a doctor

Description

Active ingredients (in each tablet) Docustate 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 (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 may indicate 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 continues over a period of 2 weeks

Section 50570-1

Do not use

  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor

Section 51727-6

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

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 softner

Laxative

Section 55106-9

Active ingredients (in each tablet)

Docustate sodium 50 mg

Sennosides 8.6 mg

Section 60561-8

Other information

  • each tablet contains: calcium 20 mg, sodium 6 mg (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 causes bowel movement in 6-12 hours
Dosage and Administration (34068-7)

Directions

  • take preferably at bedtime or as directed by a doctor

age

starting dosage

maximum dosage

adults and children 12 years of age and over

2 tablets once a day

4 tablets twice a day

children 6 to under 12

years

1 tablet once a day

2 tablets twice a day

children 2 to under 6

years

½ tablet once a day

1 tablet twice a day

children under 2 years

ask a doctor

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 (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 may indicate 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 continues over a period of 2 weeks

Section 50570-1 (50570-1)

Do not use

  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor

Section 51727-6 (51727-6)

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

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 softner

Laxative

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Docustate sodium 50 mg

Sennosides 8.6 mg

Section 60561-8 (60561-8)

Other information

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)