A&D Jr.

Name: A&D Jr.

What are some things I need to know or do while I take A&D Jr.?

  • Tell all of your health care providers that you take A&D Jr.. This includes your doctors, nurses, pharmacists, and dentists.
  • This medicine is not meant for use during pregnancy or if you are breast-feeding. If you are pregnant or breast-feeding, talk with your doctor before taking this medicine.

If OVERDOSE is suspected

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.

What do I need to tell my doctor BEFORE I take Multivitamins Capsules and Tablets?

All products:

  • If you have an allergy to this medicine or any part of this medicine (multivitamins capsules and tablets).
  • 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.

Products that have iron in them:

  • If you have too much iron in your body.

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 this medicine (multivitamins capsules and tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How is this medicine (Multivitamins Capsules and Tablets) best taken?

Use this medicine (multivitamins capsules and tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food. Take with food if it causes an upset stomach.

What do I do if I miss a dose?

  • If you take this medicine on a regular basis, take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

How do I store and/or throw out Multivitamins Capsules and Tablets?

  • 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.

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.

References

Federal Register Notice of April 9, 1971 (36 FR 6843).
The Federal Register Notice of August 2, 1973 (38 FR 20750).
The Federal Register Notice of October 17, 1980 (45 FR 69044).
Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin
B6, and Vitamin B12 and Vascular Disease (Docket No. 99P-3029). November 28, 2000.
The Federal Register Notice of March 5, 1996 (61 FR 8760).
Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects (Docket No. 91N-100H). October 10, 2000.
Code of Federal Regulations Title 21 Section 172.345.
Code of Federal Regulations Title 21 Section 101.9(j)(8).

VITAMIN B9 MECHANISM OF ACTION: Vitamin B9 is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoiesis. It also promotes white blood cell (WBC) and platelet production in vitamin B9-deficiency anemia. Vitamin B9 is associated with methylation and transformylation biochemistry.

INTERACTIONS: Talk to your healthcare practitioner and/or pharmacist before taking or using any prescription or over-the-counter medicines or herbal/health supplements alongside this product.

ADVERSE REACTIONS: Allergic reactions have been reported following the use of oral and parenteral vitamin B9. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cobalamin. Nausea, vomiting, diarrhea, transient skin rash, flushing, epigastric pain, and constipation have been associated with acetylcysteine.

Call your medical practitioner about side effects.

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the components contained in this product.

WARNINGS: Caution is recommended in patients with a history of bipolar illness. Mood elevation is possible in this population.

Caution is also recommended in patients taking anticonvulsant medications as vitamin B9 may interfere with anticonvulsant medication, and may lower seizure threshold.

Patients undergoing cancer treatment should consult their licensed medical practitioner for advice.

PRECAUTIONS: Vitamin B9 alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Vitamin B9 in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations progress.

PREGNANCY and NURSING MOTHERS: This product is not intended for use as a prenatal/postnatal multivitamin for lactating and non-lactating mothers. This product contains B vitamins plus NAC. Talk with your medical practitioner before using if pregnant or lactating.

HOW SUPPLIED: Levomefolate Calcium/Acetylcysteine/Mecobalamin/Algal Powder (6 mg-600 mg-2 mg-90.314 mg) is supplied as a coated, gray caplet debossed "V324", dispensed in bottles of 1000 caplets.

†This product is a prescription-vitamin B9 with or without other dietary ingredients that - due to increased vitamin B9 levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Based on our assessment of the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) - or similar product code, as required by pedigree reporting requirements and supply-chain control as well as - in some cases, for insurance-reimbursement applications.

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, FL 33619

REV 5/2014

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

VIRTUS
PHARMACEUTICALS

NDC† 76439-329-11

Levomefolate Calcium*/
Acetylcysteine/Mecobalamin/
Algal Powder

Algal Powder
(6 mg-600 mg-2 mg-90.314 mg)

Prescription Vitamin B9-Containing
Dietary Supplement

Rx

1000 Caplets       Made in the USA

Made in the USA

LEVOMEFOLATE CALCIUM ACETYLCYSTEINE AND MECOBALAMIN ALGAL 
levomefolate calcium, methylcobalamin, acetylcysteine and schizochytrium tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76439-329
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMEFOLATE CALCIUM (LEVOMEFOLIC ACID) LEVOMEFOLATE CALCIUM 6 mg
METHYLCOBALAMIN (METHYLCOBALAMIN) METHYLCOBALAMIN 2 mg
ACETYLCYSTEINE (ACETYLCYSTEINE) ACETYLCYSTEINE 600 mg
SCHIZOCHYTRIUM DHA OIL (SCHIZOCHYTRIUM DHA OIL) SCHIZOCHYTRIUM DHA OIL 90.314 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
POLYVINYL ALCOHOL  
CROSCARMELLOSE SODIUM  
TITANIUM DIOXIDE  
POLYETHYLENE GLYCOL 3350  
MAGNESIUM STEARATE  
TALC  
CARNAUBA WAX  
Product Characteristics
Color GRAY Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code V324
Contains     
Packaging
# Item Code Package Description
1 NDC:76439-329-11 1000 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 05/09/2014 02/15/2015
Labeler - Virtus Pharmaceuticals (969483143)
Revised: 07/2015   Virtus Pharmaceuticals
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