Gericare 303b (304)

Gericare 303b (304)
SPL v1
SPL
SPL Set ID e24638d3-7738-4185-8ce9-1845d8594cc6
Route
ORAL
Published
Effective Date 2011-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg) Docusate (50 mg)
Inactive Ingredients
Polyethylene Glycol, Unspecified Hypromellose, Unspecified Fd&c Blue No. 2 Titanium Dioxide Magnesium Stearate Microcrystalline Cellulose Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Red No. 40 Silicon Dioxide Talc

Identifiers & Packaging

Pill Appearance
Imprint: PSD21 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-12-01

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Purpose

Stool softener Stimulant laxative

How Supplied

Stool softener with stimulant laxative each tablet contains docusate sodium 50 mg sennosides 8.6 mg. Red colored, round shaped and the imprint code in PSD21. NDC: 71335-2522-1: 30 Tablets in a BOTTLE NDC: 71335-2522-2: 120 Tablets in a BOTTLE NDC: 71335-2522-3: 60 Tablets in a BOTTLE NDC: 71335-2522-4: 90 Tablets in a BOTTLE NDC: 71335-2522-5: 100 Tablets in a BOTTLE NDC: 71335-2522-6: 28 Tablets in a BOTTLE NDC: 71335-2522-7: 56 Tablets in a BOTTLE NDC: 71335-2522-8: 14 Tablets in a BOTTLE NDC: 71335-2522-9: 20 Tablets in a BOTTLE Store at controlled room temperature. Tamper Evident: Do not use if imprinted seal under cap is missing or broken. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504


Medication Information

Purpose

Stool softener

Stimulant laxative

How Supplied

Stool softener with stimulant laxative each tablet contains docusate sodium 50 mg sennosides 8.6 mg. Red colored, round shaped and the imprint code in PSD21.

NDC: 71335-2522-1: 30 Tablets in a BOTTLE

NDC: 71335-2522-2: 120 Tablets in a BOTTLE

NDC: 71335-2522-3: 60 Tablets in a BOTTLE

NDC: 71335-2522-4: 90 Tablets in a BOTTLE

NDC: 71335-2522-5: 100 Tablets in a BOTTLE

NDC: 71335-2522-6: 28 Tablets in a BOTTLE

NDC: 71335-2522-7: 56 Tablets in a BOTTLE

NDC: 71335-2522-8: 14 Tablets in a BOTTLE

NDC: 71335-2522-9: 20 Tablets in a BOTTLE

Store at controlled room temperature.

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • this product generally produces bowel movement in 6 to 12 hours
Section 50565-1

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

Section 51945-4

Docusate/ Sennosides 50/8.6 mg Tablet

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.

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.

Active Ingredient (in Each Tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • this product generally produces bowel movement in 6 to 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 right away.

Section 51945-4 (51945-4)

Docusate/ Sennosides 50/8.6 mg Tablet

Purpose

Stool softener

Stimulant laxative

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.

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

How Supplied (HOW SUPPLIED)

Stool softener with stimulant laxative each tablet contains docusate sodium 50 mg sennosides 8.6 mg. Red colored, round shaped and the imprint code in PSD21.

NDC: 71335-2522-1: 30 Tablets in a BOTTLE

NDC: 71335-2522-2: 120 Tablets in a BOTTLE

NDC: 71335-2522-3: 60 Tablets in a BOTTLE

NDC: 71335-2522-4: 90 Tablets in a BOTTLE

NDC: 71335-2522-5: 100 Tablets in a BOTTLE

NDC: 71335-2522-6: 28 Tablets in a BOTTLE

NDC: 71335-2522-7: 56 Tablets in a BOTTLE

NDC: 71335-2522-8: 14 Tablets in a BOTTLE

NDC: 71335-2522-9: 20 Tablets in a BOTTLE

Store at controlled room temperature.

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information (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 (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.

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

Docusate Sodium 50 mg

Sennosides 8.6 mg


Advanced Ingredient Data


Raw Label Data

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