1. Home
  2. Labeler Index
  3. Bryant Ranch Prepack
  4. 71335-0294
  5. Label Information: Stool Softener

FDA Label for Stool Softener

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. HOW SUPPLIED

Stool Softener Product Label

The following document was submitted to the FDA by the labeler of this product Bryant Ranch Prepack. 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.

Active Ingredient (In Each Softgel)



Docusate Sodium 100 mg


Purpose



Stool Softener Laxative


Uses



  • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 12 to 72 hours

Warnings



Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• have a sudden change in bowel habits that persists over a period of 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week

• you have rectal bleeding or fail to have a bowel movement. These

could be signs of a serious condition.

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


Otc - 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.


Directions



• adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor

• children under 12: consult a doctor

• do not exceed recommended dose


Other Information



• each softgel contains: sodium 5 mg. very low sodium

• store at 15°C-25°C(59° F-77° F)

• keep tightly closed

• product from USA or Canada

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


Inactive Ingredients



FD and C red 40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. May also contain D and C yellow 10, FD and C yellow 6 (sunset yellow), mannitol.


How Supplied



Product: 71335-0294

NDC: 71335-0294-0 50 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-1 30 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-2 100 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-3 60 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-4 120 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-5 90 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-6 180 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-7 10 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-8 28 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-9 56 CAPSULE, LIQUID FILLED in a BOTTLE


* Please review the disclaimer below.