PreFol-DHA

Name: PreFol-DHA

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take PreFol-DHA (vitamins (multiple/prenatal)) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to PreFol-DHA. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Description

PreFol-DHA™ is a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish oil-based DHA. PreFol-DHA™ are oblong, maroon softgel capsules with “M100” imprinted on one side.

Each capsule has the following active ingredient:
Folic Acid................................................................................1.2 mg

Each capsule also contains the following ingredients for nutritional supplementation:
Vitamin C (ascorbic acid) ...................................................... 28 mg
Calcium (tribasic calcium phosphate) ................................. 160 mg
Iron (ferrous fumarate) ......................................................... 26 mg
Vitamin D3 (cholecalciferol) ................................................. 400 IU
Vitamin E (d-alpha tocopherol).............................................. 30 IU
Vitamin B6 (pyridoxine hydrochloride) ................................ 25 mg
DHA (Docosahexaenoic Acid)............................................... 300 mg*
Docusate Sodium................................................................ 55 mg
*from approximately 350 mg of Omega-3s derived from approximately 380 mg

Inactive Ingredients

Capsules (Gelatin, Glycerin, Purified Water, FD&C Red #40, Titanium Dioxide, Ethyl Vanillin, FD&C Yellow #6, FD&C Blue #1), Lecithin, Soybean Oil, Yellow Bees Wax, Citric Acid, Natural Creamy Orange Flavor.

Caution

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

Patient information

PreFol-DHA™ is a prescription vitamin for use only under the direction and supervision of a licensed physician.

How supplied

PreFol-DHA™ is dispensed in bottles of 30 softgel capsules.
PRODUCT CODE 58657-100-30
KEEP OUT OF REACH OF CHILDREN.
Rx Only

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:
Method Pharmaceuticals, LLC
www.methodpharm.com
Rev. 08/13

Before, during and/or after pregnancy, one softgel capsule daily or as prescribed by a physician.

Storage

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP controlled room temperature].

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

Call your doctor about side effects. You may report side effects by calling (877) 250-3427.
KEEP OUT OF THE REACH OF CHILDREN.

Manufactured for:
Method Pharmaceuticals, LLC, Arlington, TX 76006
www.methodpharm.com

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