Vitafol Fe+ Stool Softener

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