Prenate AM

Name: Prenate AM

What do I need to tell my doctor BEFORE I take Prenate AM?

All products:

  • If you have an allergy to this medicine or any part of Prenate AM.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have too much iron in your body.

Products with vitamin A:

  • If you are taking acitretin.

Products with omega-3 fatty acids:

  • If you are taking a blood thinner.
  • If you have bleeding problems.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Prenate AM with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Black, tarry, or bloody stools.
  • Fever.
  • Very upset stomach or throwing up.
  • Very bad belly pain.
  • Throwing up blood or throw up that looks like coffee grounds.
  • Stomach cramps.

How do I store and/or throw out Prenate AM?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

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 Prenate AM (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 Prenate AM. 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

Prenate AM®

Dietary Supplement
Rx prenatal vitamin with B vitamins and Ginger
With
Quatrefolic®

Rx Only

DESCRIPTION: PRENATE® AM is a yellow, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with "Prenate" on one side and "AM" on the other.

Supplement Facts
Serving Size: 1 Tablet
Each Tablet Contains:
Vitamin B6 (Pyridoxine Hydrochloride) 75 mg
Vitamin B12 (Cyanocobalamin) 12 mcg
Calcium (as Calcium Carbonate) 200 mg
Folate (as 1.1 mg Quatrefolic® ((6S)-5,methyltetrahydrofolate glucosamine salt* CAS 1181972-37-1) molar equivalent to 600 mcg of Folic Acid) (folic acid, USP 400 mcg) 1 mg
Ginger Extract 500 mg
Lingonberry 25 mg

OTHER INGREDIENTS: Methocel K, stearic acid, magnesium stearate and silicon dioxide, dicalcium phosphate

PRECAUTIONS: Concomitant use of ginger in patients with bleeding disorders, or who are on anti-coagulant or anti-platelet therapy, may increase the risk of bleeding. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. While prescribing this nutritional supplement for pregnant women, nursing mothers or for women prior to conception, their medical condition and any drugs, herbs and/or supplements consumption should be considered.

DOSAGE AND ADMINISTRATION: One tablet daily or as directed by your doctor.

THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

DISTRIBUTED BY:
Avion Pharmaceuticals, LLC
Atlanta, GA 30350 1-888-61-AVION            Rev. 0513

The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

*Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1

PRENATE® AM is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.

Package label.principal display panel

75854-307-30

Prenate® Am
Dietary Supplement
Rx prenatal vitamin with B vitamins and Ginger
With
Quatrefolic®

PRENATE® AM’s formulation eases symptoms
commonly associated with pregnancy, including
nausea and vomiting.

30 Tablets
Rx Only

Avion
PHARMACEUTICALS

Prenate AM 
.pyridoxine hydrochloride, cyanocobalamin, calcium carbonate and folic acid tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75854-307
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 75 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
Inactive Ingredients
Ingredient Name Strength
GINGER 500 mg
LINGONBERRY 25 mg
HYPROMELLOSES  
STEARIC ACID  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL Size 22mm
Flavor Imprint Code Prenate;AM
Contains     
Packaging
# Item Code Package Description
1 NDC:75854-307-30 30 TABLET, COATED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/15/2013
Labeler - Avion Pharmaceuticals, LLC (965450542)
Revised: 06/2013   Avion Pharmaceuticals, LLC
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