White Softgel Capsule
Product Information
- Brand
- Exeltis USA
- Form
- Softgel Capsule
- Servings Per Container
- 1
- Product Type
- Non-Nutrient/Non-Botanical
- DSLD Entry Date
- 2021-01-22
Target Groups
Label Statements
General Statements: All Other Content
Sample not for sale 0642-0096-01
FDA Statement of Identity
Complete prenatal supplement with 90 mg Iron
Formulation re: Does NOT Contain
Gluten, lactose and sugar free
Formulation re: Other
+ Optional stool softener softgel
General Statements: All Other Content
Rx 3-day starter pack
Precautions re: All Other
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.
Precautions re: Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Formula re: Contains
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.
Suggested/Recommended/Usage/Directions
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.
General Statements: All Other Content
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.
Storage
Store at room temperature, approximately 15 degrees-30 degrees Celsius (59 degrees-86 degrees Fahrenheit), avoid excessive heat and moisture.
General Statements: All Other Content
See package insert for full prescribing information
Precautions re: All Other
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
Brand IP Statement(s) re: (c), (TM), (SM)
Vitafol is a trademark of Exeltis USA, Inc.
Brand IP Statement(s) re: (c), (TM), (SM)
U.S. Patent pending
Precautions re: Pregnant or Nursing or Prescription Medications
Ask your doctor before use if you are breastfeeding.
Formulation re: Other
Manufactured in USA.
Supplement Facts Panel
* Percent Daily Values are based on a 2,000 calorie diet.
† Daily Value not established.
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