Label: NON-HABIT FORMING STOOL SOFTENER- docusate sodium capsule, liquid filled
- NDC Code(s): 42254-125-00, 42254-125-30, 42254-125-60
- Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 0536-3756
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredient (in each softgel capsule)
Docusate Sodium 100mgClose
- Relieves occasional constipation.
- Generally produces bowel movement within 12 to72 hours.
- Warnings - Do not use
- for longer than one week
- if you are taking mineral oil
- when abdominal pain, nausea, or vomiting are present
Ask a doctor before use if
you have a sudden change in bowel habits that lasts over two weeks
Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
Stop use and ask a doctor if
- you experience rectal bleeding
- you fail to have a bowel movement after using this product
These may indicate a serious condition.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- adults and children over 12 years and over:1 capsule once daily or in divided doses
- children 6 to under 12 years: 1 capsule once daily
- children under 6 years: ask a doctor
- Other information
- store at controlled room temperature 15 - 30 degrees C (59-86 degrees F)
Each capsule contains sodium 6mgClose
- Inactive Ingredients
edible white ink, FDandC Red No. 40, FDandC Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.Close
- Questions or comments?
Call 1-800-645-2158, 9am - 5am ET Monday - FridayClose
- Principal Display Panel
- INGREDIENTS AND APPEARANCE
NON-HABIT FORMING STOOL SOFTENER
docusate sodium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42254-125(NDC:0536-3756) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SORBITOL Product Characteristics Color orange (orange) Score no score Shape OVAL (OVAL) Size 13mm Flavor Imprint Code P51 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42254-125-30 30 in 1 BOTTLE 2 NDC:42254-125-60 60 in 1 BOTTLE 3 NDC:42254-125-00 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/29/2012 Labeler - Rebel Distributors Corp (118802834) Registrant - PSS World Medical, Inc. (101822862) Establishment Name Address ID/FEI Business Operations PSS World Medical, Inc. 791528623 REPACK(42254-125) Establishment Name Address ID/FEI Business Operations STAT RX USA LLC 786036330 REPACK(42254-125) Establishment Name Address ID/FEI Business Operations Dispensing Solutions, Inc. 066070785 RELABEL(42254-125), REPACK(42254-125) Establishment Name Address ID/FEI Business Operations SCRIPT PAK 964420108 RELABEL(42254-125), REPACK(42254-125) Establishment Name Address ID/FEI Business Operations Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-125) Establishment Name Address ID/FEI Business Operations Rebel Distirbutors Corp. 118802834 RELABEL(42254-125), REPACK(42254-125)