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  5. Label Information: Docusate Sodium - Stool Softener Laxative

FDA Label for Docusate Sodium - Stool Softener Laxative

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?
    11. PACKAGING

Docusate Sodium - Stool Softener Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




Active Ingredient (In Each Softgel)



Docusate Sodium 100 mg


Purpose



Stool softener laxative


Uses



• for relief of occasional constipation (irregularity)
• This generally produces a bowel movement within 12 to 72 hours.


Warnings



Ask a doctor before use if you have
• abdominal pain, nausea, or vomiting
• a sudden change in bowel habits that lasts over 14 days

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Stop use and ask a doctor if
• you have rectal bleeding or no bowel movement after using this product.
These can be signs of a serious condition
• you need to use a laxative for more than 1 week

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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children
Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.


Directions



• take softgels with a full glass (8 oz) of water

adults and children 12 years of age and oldertake 1 to 3 softgels daily or as directed
by a doctor. This dose may be taken as a single daily dose or in divided doses.
children 6 to under 12 years of agetake 1 softgel daily or as directed by a doctor
children under 6 years of ageask a doctor


Other Information



• each softgel contains: sodium 10 mg (very low sodium)
• store at 25°C (77°F) in a dry place. Avoid excessive heat 40°C (140°F).


Inactive Ingredients



edible white ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution


Questions Or Comments?



(800)616-2471


Packaging



Major1 - 09047183 1

Major1 - 09047183 1


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