White Softgel Capsule

Basic Information

Product Label

Product label for White Softgel Capsule
Full Name: White Softgel Capsule
Brand: Exeltis USA none
Product Type: Non-Nutrient/Non-Botanical
Physical State: Softgel Capsule
Product Version Code: (Rev. 08/15)

Contact Information

Distributed by

Name: Exeltis USA, Inc.
Address:Florham Park, NJ, 07932
Phone: 1-877-324-9349
Types: Distributor

Product Details

Net Contents

N/A(0 Not Present)

Serving Sizes

Unit:White Softgel Capsule(s)
Quantity:1 - 1
Daily Servings:1 - 1

Target Groups

Pregnant WomenAdult Female (18 - 50 Years)Gluten FreeSugar Free

Servings Per Container

1

Ingredients & Nutrition

Group: Edible ink

Docusate Sodium

non-nutrient/non-botanical

Group: Docusate Sodium

DSS

non-nutrient/non-botanical

Group: Docusate Sodium

Also known as: Docusate Sodium

Group: Glycerol

Group: Collagen

Hydrolyzed collagen is a form of collagen that has been broken down into smaller peptides, ensuring ease of digestion and absorption in the human body. Collagen is the most abundant protein in the body and is essential for maintaining healthy skin, bones, and connective tissues. Hydrolyzed collagen is often used as a supplement to support skin health, joint health, and overall wellness.

Also known as: Gelatin

PEG

other

Group: Polyethylene glycol

Also known as: Polyethylene Glycol

Group: Polyethylene glycol

Also known as: PEG, Macrogol

UNII Code: 3WJQ0SDW1A

Group: Propylene Glycol

UNII Code: 6DC9Q167V3

Sorbitol

non-nutrient/non-botanical

Group: Sorbitol

UNII Code: 506T60A25R

Product 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.

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