Basic Drugs - Senna-s - Laxative With Stool Softener (0761-0910)

Basic Drugs - Senna-s - Laxative With Stool Softener (0761-0910)
SPL v5
SPL
SPL Set ID d32b9956-fc04-8d64-e053-2a95a90a17b3
Route
ORAL
Published
Effective Date 2021-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg) Sennosides (8.6 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Yellow No. 10 Anhydrous Dibasic Calcium Phosphate Fd&c Yellow No. 6 Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: PH32 Shape: round Color: orange Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-15

Description

Docusate Sodium 50mg Sennosides from Senna Concentrate 8.6mg

Purpose

Stool softener Laxative


Medication Information

Purpose

Stool softener

Laxative

Description

Docusate Sodium 50mg Sennosides from Senna Concentrate 8.6mg

Uses
  • relieves ocasional constipation (irregularity)
  • generally produces bowel movement in 6-12 hours.
Section 50565-1

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

Section 51945-4

Warnings

Do not use

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

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that persists over a period of 2 weeks

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

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

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 of age and over 2-4 tablets daily
children 6 to under 12 years 1-2 tablets daily
children 2 to under 6 years up to tablet daily
children under 2 years of age ask a doctor

Questions?

937-898-4010

Other Information
  • each tablet contains: calcium 10 mg
  • each tablet contains: sodium 3 mg
  • store between 15° - 30°C (59° - 86°F)
Inactive Ingredients

Croscarmellose sodium, D&C Yellow #10, dicalcium phosphate, FD&C Yellow # 6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Active Ingredient (in Each Tablet)

Docusate Sodium 50mg

Sennosides from Senna Concentrate 8.6mg


Structured Label Content

Uses
  • relieves ocasional constipation (irregularity)
  • generally produces bowel movement in 6-12 hours.
Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Purpose

Stool softener

Laxative

Warnings

Do not use

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

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that persists over a period of 2 weeks

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

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

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 of age and over 2-4 tablets daily
children 6 to under 12 years 1-2 tablets daily
children 2 to under 6 years up to tablet daily
children under 2 years of age ask a doctor

Questions?

937-898-4010

Other Information (Other information)
  • each tablet contains: calcium 10 mg
  • each tablet contains: sodium 3 mg
  • store between 15° - 30°C (59° - 86°F)
Inactive Ingredients (Inactive ingredients)

Croscarmellose sodium, D&C Yellow #10, dicalcium phosphate, FD&C Yellow # 6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Docusate Sodium 50mg

Sennosides from Senna Concentrate 8.6mg


Advanced Ingredient Data


Raw Label Data

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