Sennosides And Docusate Sodium Tablets

Sennosides And Docusate Sodium Tablets
SPL v4
SPL
SPL Set ID 4b84d5d7-43cf-47bb-af59-088550c3a0bc
Route
ORAL
Published
Effective Date 2021-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: PSD22 Shape: round Color: orange Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-03

Description

Docusate Sodium         50 mg Sennosides            8.6 mg

Purpose

Stool softener Laxative


Medication Information

Purpose

Stool softener

Laxative

Description

Docusate Sodium         50 mg Sennosides            8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • this product generally produces a bowel movement in 6 to 12 hours
Section 42229-5

The drug product contained in this package is from NDC # 57896-555, Geri-Care Pharmaceuticals Corp.

Distributed by:

American Health Packaging, Columbus, Ohio 43217         Product of India

762201

0462201/0825

Warnings

Do not use

  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor
Directions
  • do not exceed 8 tablets in 24 hours
  • Adults and children 12 years of age and older take 2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor; the maximum dose should be 4 tablets in the morning and 4 tablets at bedtime
  • Children under 12 years ask a doctor
Other Information
  • each tablet contains: calcium 20 mg, sodium 3 mg. Very low sodium.
  • store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F).
  • FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Active Ingredients

Docusate Sodium         50 mg

Sennosides            8.6 mg

Inactive Ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

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.

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.

Ask A Doctor Before Use If You Have
  • stomach pain, nausea or vomiting
  • noticed a sudden change in bowel habits that lasts over two weeks
Package/label Display Panel – Carton – 8.6 Mg/50 Mg

NDC 60687- 622-01

Sennosides and Docusate Sodium Tablets

Natural Vegetable Laxative with Stool Softener

8.6 mg/50 mg

100 Tablets (10 x 10)

Drug Facts

Active ingredients (in each tablet)......................................................................Purpose


Docusate Sodium 50 mg...............................................................................Stool softener

Sennosides 8.6 mg............................................................................................... Laxative

The drug product contained in this package is from

NDC # 57896-555, Geri-Care Pharmaceuticals Corp.         Product of India

Distributed by:

American Health Packaging, Columbus, Ohio 43217

762201

0462201/0825

Package/label Display Panel – Blister – 8.6 Mg/50 Mg

Sennosides and Docusate

Sodium Tablet

Laxative/Stool Softener

8.6 mg/50 mg


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • this product generally produces a bowel movement in 6 to 12 hours
Section 42229-5 (42229-5)

The drug product contained in this package is from NDC # 57896-555, Geri-Care Pharmaceuticals Corp.

Distributed by:

American Health Packaging, Columbus, Ohio 43217         Product of India

762201

0462201/0825

Purpose

Stool softener

Laxative

Warnings

Do not use

  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor
Directions
  • do not exceed 8 tablets in 24 hours
  • Adults and children 12 years of age and older take 2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor; the maximum dose should be 4 tablets in the morning and 4 tablets at bedtime
  • Children under 12 years ask a doctor
Other Information (Other information)
  • each tablet contains: calcium 20 mg, sodium 3 mg. Very low sodium.
  • store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F).
  • FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Active Ingredients (Active ingredients)

Docusate Sodium         50 mg

Sennosides            8.6 mg

Inactive Ingredients (Inactive ingredients)

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

Stop Use and Ask A Doctor If (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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain, nausea or vomiting
  • noticed a sudden change in bowel habits that lasts over two weeks
Package/label Display Panel – Carton – 8.6 Mg/50 Mg (Package/Label Display Panel – Carton – 8.6 mg/50 mg)

NDC 60687- 622-01

Sennosides and Docusate Sodium Tablets

Natural Vegetable Laxative with Stool Softener

8.6 mg/50 mg

100 Tablets (10 x 10)

Drug Facts

Active ingredients (in each tablet)......................................................................Purpose


Docusate Sodium 50 mg...............................................................................Stool softener

Sennosides 8.6 mg............................................................................................... Laxative

The drug product contained in this package is from

NDC # 57896-555, Geri-Care Pharmaceuticals Corp.         Product of India

Distributed by:

American Health Packaging, Columbus, Ohio 43217

762201

0462201/0825

Package/label Display Panel – Blister – 8.6 Mg/50 Mg (Package/Label Display Panel – Blister – 8.6 mg/50 mg)

Sennosides and Docusate

Sodium Tablet

Laxative/Stool Softener

8.6 mg/50 mg


Advanced Ingredient Data


Raw Label Data

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