OTC Medication Information: Stool Softener with Laxative

STOOL SOFTENER WITH LAXATIVE- sennosides and docusate sodium tablet, film coated
PHARMACY VALUE ALLIANCE, LLC

Active ingredient (in each tablet)

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool softener

Stimulant laxative

Uses

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

Warnings

Do not use

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

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

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.

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 over take 2-4 tablets daily
children under 12 years of age ask a doctor

Other information

  • each tablet contains: calcium 20 mg, sodium 3 mg
  • store at controlled room temperature
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • product of India

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C blue #2 lake, FD&C red #40 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

Package Label

304
(click image for full-size original)

STOOL SOFTENER WITH LAXATIVE
docusate sodium and sennosides tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-623
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SENNOSIDES (SENNOSIDES) SENNOSIDES 8.6 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
TALC
POLYETHYLENE GLYCOL, UNSPECIFIED
HYPROMELLOSES
FD&C BLUE NO. 2
TITANIUM DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
FD&C RED NO. 40
SILICON DIOXIDE
Product Characteristics
Color red Score no score
Shape ROUND Size 10mm
Flavor Imprint Code PSD21
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68016-623-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68016-623-25 250 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug 505G(a)(3) 12/01/2019
Labeler — PHARMACY VALUE ALLIANCE, LLC (101668460)
Registrant — Geri-Care Pharmaceutical Corp (611196254)

Revised: 12/2023 PHARMACY VALUE ALLIANCE, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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