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

Docusate Sodium

non-nutrient/non-botanical
Amount: 50 mg
Serving Size: 1 White Softgel Capsule(s)
Pregnant and Lactating: % (Daily Value not established)

Group: Docusate Sodium

Group: Edible ink

Citric Acid

non-nutrient/non-botanical

Group: Citric Acid

DSS

non-nutrient/non-botanical

Group: Docusate Sodium

Also known as: Docusate Sodium

Gelatin

protein

Group: Gelatin

Group: Glycerol

Group: Collagen

Also known as: Gelatin

PEG

other

Group: Polyethylene glycol

Also known as: Polyethylene Glycol

Group: Polyethylene glycol

Also known as: PEG

Group: Water

Sorbitol

non-nutrient/non-botanical

Group: Sorbitol

UNII Code: 506T60A25R

Group: Titanium Dioxide

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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