Vitafol Fe+ Stool Softener

Basic Information

Product Label

Product label for Vitafol Fe+ Stool Softener
Full Name: Vitafol Fe+ Stool Softener
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

3 White Softgel Capsule(s)(3 White Softgel Capsule(s))

Serving Sizes

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

Target Groups

Pregnant Women

Servings Per Container

3

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

Group: Water

UNII Code: 059QF0KO0R

Product Statements

General Statements: All Other Content

Sample not for sale 0642-0096-01 Rx

Brand IP Statement(s) re: (c), (TM), (SM)

U.S. patent pending

Formulation re: Other

+ Optional stool softener softgel

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.

Precautions re: Pregnant or Nursing or Prescription Medications

Ask your doctor before use if you are breastfeeding.

Precautions re: All Other

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 movements 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.

Formula re: Type

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

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 C (59 degrees-86 degrees F), avoid excessive heat and moisture.

General Statements: All Other Content

Rx See package insert for full prescribing information

Formulation re: Other

Manufactured in USA.

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. U.S. patent pending Life'sDHA is a trademark of DSM. U.S. Patent No. 7,163,811 and 7,824,892 Metafolin is a trademark of Merck KGaA, Darmstadt, Germany. U.S. Patent No. 6,441,168 B1; 5,997,915; 6,254,904; 6,808,725; 7,172,778 and 7,674,490

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