Consumer Information for: VITAMIN A (200,000 IU) AND VITAMIN E (40 IU) ORAL LIQUID PREPARATION

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Vitamin A (200,000 IU) and Vitamin E (40 IU) Oral Liquid Preparation is intended to be used only in young children who are 12 months to 59 months of age to prevent symptoms of Vitamin A deficiency (or VAD). These symptoms can include night blindness, buildup of a protein called keratin in the eye (known as Bitot’s spots, they appear as irregular foamy shapes on the eye) and dry eyes (known as xerophthalmia).

The World Health Organization recommends Vitamin A treatment in places where VAD is a public health problem as follows:

  • When night blindness occurs in 1% or greater in children who are 24 to 59 months of age, or
  • Where VAD (which is measured in the blood as serum retinol 0.70 μmol/L or lower) occurs in 20% or higher in children who are 6 to 59 months of age.
What it does

Vitamin A is a co-factor in many biological processes in the body, including those responsible for good vision.

What the medicinal ingredient is

Vitamin A (all-trans-retinyl palmitate) and Vitamin E (all-rac-alpha-tocopheryl acetate)

What the non-medicinal ingredients are

soy bean oil, gelatin, glycerin, FD&C blue #1, FD&C red #40, FD&C yellow #5, titanium dioxide, ethyl vanillin May contain trace levels of lecithin

What dosage form it comes in

Vitamin A (200,000 IU) and Vitamin E (40 IU) Oral Liquid Preparation will be provided as a red tube shaped softgel capsule with a nipple tip to allow for cutting and squeezing out the drops for a one time dose.

The softgel capsules are packaged in plastic bottles. Each bottle contains 500 softgel capsules.

When it should not be used
  • Your child is younger than 12 months of age
  • You are not in an area when vitamin A deficiency is a public health concern
  • You or your child are allergic to any of the ingredients in Vitamin A (200,000 IU) and Vitamin E (40 IU) Oral Liquid Preparation
  • You or your child have symptoms of having too much Vitamin A in the body, such as; changes in vision, bone pain, and skin changes (known as hypervitaminosis A)
  • You are pregnant or want to become pregnant, because high doses of vitamin A have caused birth defects.

This product is only meant to be given to children who are 12 months of age to 59 months of age.

Warnings and precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before Vitamin A (200,000 IU) and Vitamin E (40 IU) Oral Liquid Preparation is given to your child. Talk about any health conditions or problems your child may have, including if:

  • Your child has a cold or flu (respiratory infections)
  • Your child requires a vaccine, especially measles vaccine and diphtheria-tetanus pertussis (DTP) vaccine
  • You are breastfeeding, as additional vitamin A can be excreted in human breast milk and passed to your infant.

Other warnings you should know about:
There are many different vitamins in your child’s normal diet. If your child has a deficiency in his/her diet, there would probably be a lack multiple vitamins, not just lack Vitamin A.

High doses of Vitamin A should only be given to children in areas where there is known deficiency of Vitamin A.

Take special care to avoid accidental exposure of your child to multiple large doses over a short period of time. The long term effect of high doses of Vitamin A in children (especially on the effects on their bones) has not been studied.

Take special care if your child has a chest (or respiratory) infection before you give Vitamin A.

Tell your healthcare professional about all the medicines you or your child are taking, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication
  • Diphtheria-tetanus-pertussis (DTP) vaccine: There is potential interaction between Vitamin A supplementation and vaccination; children should never be given high doses of Vitamin A with DTP vaccine.
  • Measles vaccination: Giving Vitamin A with the measles vaccine may cause vomiting, loose stools, fever and irritability within 24 hours of receiving the vaccine.
  • Calcium: Taking large doses of Vitamin A for long periods of time can cause bone loss.
  • Vitamin D: Vitamin A may affect the action of Vitamin D.
  • Vitamin E: Large doses of Vitamin E can affect the absorption of Vitamin A.
  • Zinc: Lack of zinc may affect the breakdown of Vitamin A in the body.

Vitamin A may interact with other nutrients; these effects have not been studied and may not be fully known.

Proper use of this medication
  • Cut capsule end.
  • Squeeze drops into child’s mouth until the capsule is empty.
  • Do not put the capsule into your child’s mouth or let them swallow it.

Usual dose

Your healthcare professional will recommend Vitamin A (200,000 IU) and Vitamin E (40 IU) Oral Liquid Preparation for your child who is 12 months to 59 months of age, given every 4-6 months. The dose will be given by a healthcare professional.

If your child is 6 months to 11 months of age, you should refer to the Patient Medication Information for a different medication, Vitamin A (100,000 IU) and Vitamin E (20 IU) which is administered as a single dose only.

Overdose

Do not give your child more than 1 dose every 4-6 months. Signs and effects of overdose may be delayed and may not show until 8 to 24 hours after taking the medication. These side effects can include; feeling sick, vomiting, diarrhea, changes in behavior, and skin changes (itching of the skin, redness, or peeling).

If you think you have taken too much Vitamin A (200,000 IU) and Vitamin E (40 IU) Oral Liquid Preparation, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

For children 12-59 months of age, the recommended dose is Vitamin A (200,000 IU) and Vitamin E (40 IU) Oral Liquid Preparation administered by a healthcare professional every 4 to 6 months.

Side effects and what to do about them

Most common side effects are mild and may include skeletal abnormalities, bone tenderness and pain, increased intracranial pressure, peeling skin, brittle nails, mouth fissures, hair loss, fever, headache, lethargy, irritability, weight loss, vomiting, swollen liver, loose stools, headache, irritability, and feeling sick. These side effects usually disappear within 24 to 48 hours after giving Vitamin A.

These are not all the possible side effects that your child may have after taking Vitamin A (200,000 IU) and Vitamin E (40 IU) Oral Liquid Preparation. If your child has any troublesome side effect not listed here, or affects their usual daily activities, contact your healthcare professional. Please also see Warnings and Precautions.

Reporting side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:

  • Online at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
      Health Canada, Postal Locator 0701E
      Ottawa, ON
      K1A 0K9
    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

You can also contact your local health authority or the World Health Organization (WHO) to report a serious and unexpected side effect.

How to store

Vitamin A (200,000 IU) and Vitamin E (40 IU) Oral Liquid Preparation
The container is kept tightly closed, protected from moisture and light, in a cool, dry place. Temperatures above 30°C and high humidity should be avoided.

Keep out of reach and sight of children.

More information
  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website www.nutricorp.com or by calling Nutricorp International, 1-888-446-8874.

This leaflet was prepared by Nutricorp International.

Last Revised April 5, 2016

Date modified: