Folet DHA

Name: Folet DHA

Folet DHA Dosage

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal multivitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your prenatal multivitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal multivitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal multivitamins in their original container. Storing vitamins in a glass container can ruin the medication.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What are some things I need to know or do while I take Folet DHA?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Folet DHA.
  • If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Folet DHA) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All products:

  • Follow how to take Folet DHA as you have been told by your doctor. Do not use more than you were told to use.
  • Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take this medicine.
  • Take with a full glass of water.
  • Do not take antacids within 2 hours of Folet DHA.
  • Do not take dairy products with this medicine. Dairy products may make Folet DHA not work as well.
  • Follow the diet and workout plan that your doctor told you about.

Caplet:

  • This medicine may be chewed or swallowed whole.

Chewable tablet:

  • Chew well before swallowing.

Twist-off softgel:

  • Twist the small end off from the softgel. Squeeze the contents right into your mouth or into juice to drink.

What do I do if I miss a dose?

  • 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 Folet DHA?

  • 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.

Description

Folet DHA combination pack is a prescription prenatal vitamin and mineral supplementation with DHA taken through pregnancy and during the portnatal period for both lactating and non-lactating mothers. Folet DHA combination pack is also useful in improving nutritional status prior to conception.

It is recommended that for all women folate levels should be high for at least one month prior to possible conception and continued at that level for the first three months of pregnancy.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

To report a serious adverse event or to obtain product information, contact (866) 703-3508.

Folet DHA 
dha (docosahexaenoic acid), vit.a (beta-carotine), vit.c (ascorbic acid), vit.d-3 (cholecalciferol), vit.e (d-alpha-tocopheryl acetate), vit.b-1 (thiamine hcl), vit.b-2 (riboflavin), vit.b-3 (niacinamide), vit.b-6 (pyridoxine hcl), folate (1.85 mg (6s)-5-methyltetrahydrofolate-quatrefolic), vit.b-12 (cyanocobalamin), iron (carbonyl iron -ferronyl and ferrous bis-glycinate chelate -ferrochel), magnesium (magnesium oxide), zinc (zinc bis-glycinate chelate -traacs), selenium (sodium selenate), docusate sodium kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67555-153
Packaging
# Item Code Package Description
1 NDC:67555-153-30 1 KIT in 1 PACKAGE
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 30 
Part 2 1 BOTTLE 30 
Part 1 of 2
Folet DHA 
vit.a (beta-carotine), vit.c (ascorbic acid), vit.d-3 (cholecalciferol), vit.e (d-alpha-tocopheryl acetate), vit.b-1 (thiamine hcl), vit.b-2 (riboflavin), vit.b-3 (niacinamide), vit.b-6 (pyridoxine hcl), folate (1.85 mg (6s)-5-methyltetrahydrofolate-quatrefolic), vit.b-12 (cyanocobalamin), iron (carbonyl iron -ferronyl and ferrous bis-glycinate chelate -ferrochel), magnesium (magnesium oxide), zinc (zinc bis-glycinate chelate -traacs), selenium (sodium selenate), docusate sodium tablet
Product Information
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETA CAROTENE (.BETA.-CAROTENE) BETA CAROTENE 2700 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 18 [iU]
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE HYDROCHLORIDE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 40 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
FERROUS BISGLYCINATE (FERROUS CATION) FERROUS CATION 38 mg
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 30 mg
ZINC GLYCINATE (ZINC CATION) ZINC GLYCINATE 10 mg
SELENIUM (SELENIUM) SELENIUM 65 ug
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
METHACRYLIC ACID  
CROSCARMELLOSE SODIUM  
GELATIN  
SHELLAC  
HYPROMELLOSES  
STEARIC ACID  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
CROSPOVIDONE  
TALC  
SODIUM BENZOATE  
SILICON DIOXIDE  
STARCH, CORN  
TRIACETIN  
TITANIUM DIOXIDE  
CITRIC ACID MONOHYDRATE  
SODIUM LAURYL SULFATE  
MAGNESIUM STEARATE  
SOYBEAN  
POVIDONE  
MINERAL OIL  
FD&C RED NO. 40  
FD&C BLUE NO. 2  
POLYETHYLENE GLYCOLS  
SODIUM ASCORBATE  
TOCOPHEROL  
TRICALCIUM PHOSPHATE  
C10-18 TRIGLYCERIDES  
GLYCERYL MONOSTEARATE  
TRIETHYL CITRATE  
SORBIC ACID  
ASCORBYL PALMITATE  
POLYSORBATE 80  
METHYLPARABEN  
PROPYLPARABEN  
Product Characteristics
Color purple Score 2 pieces
Shape OVAL Size 17mm
Flavor Imprint Code FOLET
Contains     
Packaging
# Item Code Package Description
1 30 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/28/2014
Part 2 of 2
Folet DHA 
docosahexaenoic acid (dha) capsule, liquid filled
Product Information
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 350 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
METHACRYLIC ACID  
WATER  
POLYETHYLENE GLYCOLS  
TALC  
HYPROMELLOSES  
MINERAL OIL  
Product Characteristics
Color yellow Score no score
Shape OVAL Size 14mm
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 30 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/28/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/28/2014
Labeler - Pronova Corporation (111421496)
Revised: 09/2014   Pronova Corporation
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