191r_albertsons_21130-998_sennosides Usp, 8.6 Mg Tablets

191r_albertsons_21130-998_sennosides Usp, 8.6 Mg Tablets
SPL v3
SPL
SPL Set ID f2c529e4-6738-377c-e053-2995a90aaf38
Route
ORAL
Published
Effective Date 2023-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides A And B (8.6 mg)
Inactive Ingredients
Croscarmellose Sodium Magnesium Stearate Dibasic Calcium Phosphate Dihydrate Mineral Oil Hypromelloses Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: TCL080 Shape: round Color: brown Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-12

Description

Active ingredient (in each tablet) Sennosides 8.6 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • relieves occasional constipation (irregularity)
  • generally produces 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 ingredient (in each tablet) 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

  • laxative products for longer than 1 week unless directed by a doctor
Section 51727-6

Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

Section 51945-4

Section 53413-1

Questions or comments? 1-877-290-4008

Section 53414-9

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

Section 55105-1

Purpose

Laxative

Section 55106-9

Active ingredient (in each tablet)

Sennosides 8.6 mg

Section 60561-8

Other information

  • each tablet contains: calcium 25 mg, sodium 2 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 6-12 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

  • laxative products for longer than 1 week unless directed by a doctor
Section 51727-6 (51727-6)

Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 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)

Purpose

Laxative

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Sennosides 8.6 mg

Section 60561-8 (60561-8)

Other information

  • each tablet contains: calcium 25 mg, sodium 2 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

All Sections (JSON)