White Softgel Capsule
Product Overview
Brand: Exeltis USA
Net Contents: N/A
Serving Size (Overview): 1 White Softgel Capsule(s)
Product Type: Non-Nutrient/Non-Botanical [A1309]
Form: Softgel Capsule [E0161]
Date Entered: Jan 22, 2021
Market Status: On Market
Suggested Use (Overview): Directions for Use: During pregnancy take one purple softgel capsule daily; or as directed by a physician. Take one white softgel daily to help maintain bowel regularity; or as needed to relieve occasional constipation.
Product Self-Roles:
- No specific self-roles defined.
Dietary Supplement Facts
| Ingredient | Category | Amount Per Serving | Unit | % Daily Value | Target Group | Serving Size (Fact) |
|---|---|---|---|---|---|---|
| Docusate Sodium | non-nutrient/non-botanical | 50 | mg | N/A | Pregnant and Lactating | 1 White Softgel Capsule(s) |
Other Ingredients
Gelatin; Sorbitol; Polyethylene Glycol; Glycerin; purified Water; Propylene Glycol; Titanium Dioxide; Citric Acid; black edible Ink
Label Statements
Other
- Sample not for sale0642-0096-01 Rx3-day starter pack How Supplied: Vitafol Fe+ is available as a purple oval shaped softgel capsule imprinted 'EX0096' and one white oval shaped softgel capsule imprinted '50'. Available in box of Unit-Dose pack of 30 (6 child resistant blister cards of 5+5 softgel capsules) NDC 0642-0096-30 and as professional samples NDC 0642-0096-01. See package insert for full prescribing information
Statement of Identity
- Complete prenatal supplement with 90 mg Iron
Formulation
- Gluten lactose and sugar free + Optional stool softener softgel A separate (white) softgel capsule containing docusate sodium is provided to help maintain bowel regularity and to relieve occasional constipation associated with pregnancy or iron supplementation. Manufactured in USA.
Precautions
- Warnings/Precautions: Ask a doctor before use if you have stomach pain nausea or vomiting; or 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 or other laxative products. Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using this product as these could be signs of a serious condition. Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away. You should call your doctor for medical advice about adverse events. To report an adverse event or obtain product information contact 1-877-324-9349 Ask your doctor before use if you are breastfeeding.
Suggested Use
- Directions for Use: During pregnancy take one purple softgel capsule daily or as directed by a physician. Take one white softgel daily to help maintain bowel regularity or as needed to relieve occasional constipation.
Product Specific Information
- Store at room temperature approximately 15 degrees-30 degrees Celsius (59 degrees-86 degrees Fahrenheit) avoid excessive heat and moisture.
Branding Statement(s)
- Vitafol is a trademark of Exeltis USA Inc. U.S. Patent pending
Associated Company Information & Roles
Exeltis USA Inc.
Florham Park,
NJ
07932
Roles for this Product:
- Distributor