3052r - Major

3052r - Major
SPL v1
SPL
SPL Set ID 1768b470-2808-fa46-e063-6394a90ac8d9
Route
ORAL
Published
Effective Date 2024-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg) Sennosides (8.6 mg)
Inactive Ingredients
Maltodextrin Croscarmellose Sodium Starch, Corn Sodium Lauryl Sulfate Magnesium Stearate Polyethylene Glycol 400 Stearic Acid Dibasic Calcium Phosphate Dihydrate Fd&c Yellow No. 6 Aluminum Lake Hypromelloses Titanium Dioxide Fd&c Blue No. 1 Aluminum Lake Fd&c Red No. 40 Aluminum Lake Microcrystalline Cellulose Sodium Benzoate Talc Light Mineral Oil

Identifiers & Packaging

Pill Appearance
Imprint: 49;0 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-01

Description

Active ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg


Medication Information

Description

Active ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
Section 34088-5

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

Section 42229-5

Keep this carton for complete product information

Tamper Evident:

Do not use if sealed blister units are broken or damaged.

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50569-3

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over two weeks
Section 50570-1
  • laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil, unless told to do so by a doctor
Section 51727-6

corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide.

Section 51945-4

Major

NDC 0904-7440-61

Unit Dose

Sennosides/Docusate Sodium

8.6mg/50mg

Stool Softener/Stimulant Laxative

100 Tablets

Section 53413-1

Questions or comments? 1-800-231-4670

Section 53414-9

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

Section 55105-1

Purposes

Stool softener

Stimulant laxative

Section 60561-8
  • each tablet contains: calcium 5 mg
  • Store in a dry place at 15° – 30°C (59° – 86°F).
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 6 to under 12 years of age take 1-2 tablets daily
    children 2 to under 6 years of age take up to 1 tablet daily
    children under 2 years ask a doctor

Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

Keep this carton for complete product information

Tamper Evident:

Do not use if sealed blister units are broken or damaged.

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over two weeks
Section 50570-1 (50570-1)
  • laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil, unless told to do so by a doctor
Section 51727-6 (51727-6)

corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide.

Section 51945-4 (51945-4)

Major

NDC 0904-7440-61

Unit Dose

Sennosides/Docusate Sodium

8.6mg/50mg

Stool Softener/Stimulant Laxative

100 Tablets

Section 53413-1 (53413-1)

Questions or comments? 1-800-231-4670

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Stool softener

Stimulant laxative

Section 60561-8 (60561-8)
  • each tablet contains: calcium 5 mg
  • Store in a dry place at 15° – 30°C (59° – 86°F).
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 6 to under 12 years of age take 1-2 tablets daily
    children 2 to under 6 years of age take up to 1 tablet daily
    children under 2 years ask a doctor

Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg


Advanced Ingredient Data


Raw Label Data

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