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

Purpose

Stool softener Laxative

Description

Docusate Sodium 50mg Sennosides from Senna Concentrate 8.6mg


Medication Information

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.

Active Ingredient

Docusate Sodium 50mg

Sennosides from Senna Concentrate 8.6mg

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

Stool softener

Laxative

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

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

Description

Docusate Sodium 50mg Sennosides from Senna Concentrate 8.6mg

Questions?

937-898-4010

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


Structured Label Content

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.

Active Ingredient (Active ingredient (in each tablet))

Docusate Sodium 50mg

Sennosides from Senna Concentrate 8.6mg

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

Stool softener

Laxative

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

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

Questions?

937-898-4010

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)


Advanced Ingredient Data


Raw Label Data

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