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Seven Seas Cod Liver Oil Capsules

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REGULATORY TEXT - COMBINED LABEL-LEAFLET

ORIGINAL PURE COD LIVER OIL CAPSULES, PL 01932/0259

Top of Label

CHECK SEAL IS INTACT BEFORE PURCHASE TO OPEN SCORE ALONG DOTTED LINE Front of Label (design panel)

SEVEN SEAS ORIGINAL PURE COD LIVER OIL CAPSULES For the relief of joint pains & stiffness 120 Capsules

Front of Label (text panels)

Ingredients

Each capsule contains 0.32 ml Pure Cod Liver Oil containing eicosapentaenoic acid (EPA) 26 mg, docosahexaenoic acid (DHA) 24 mg, retinol (vitamin A) 670IU, colecalciferol (vitamin D3) 67IU and alpha tocopheryl acetate (vitamin E) 0.3IU.

How to take

For oral use. Not recommended for children under 6 years. Do not exceed the recommended dose. The capsules should be swallowed with water.

Adults and children over 6 years: As a dietary supplement (to help keep joints pain free and supple): Take 1-2 capsules three times a day.

If you are pregnant, likely to become pregnant or breast feeding: Take 1 capsule three times a day only on the advice of a doctor.

For mild to moderate vitamin deficiency: Take 1-3 capsules three times a day, depending upon the age of the patient and the severity of the condition.

How to store

KEEP ALL MEDICINES OUT OF REACH AND SIGHT OF CHILDREN

Store under cool dry conditions, away from sunlight and direct heat. Do not use after the expiry date shown on the label.

Please take any unused medicine back to your pharmacist.

Product License holder and manufacturer:

Seven Seas Limited, Hedon Road, Marfleet, Hull, HU9 5NJ, UK.

Seven Seas and Ocean Gold are registered Trade Marks. Seven Seas a company of Merck KGaA.

PL 01932/0259

Peel here but do not remove.

Reverse of peelable Label

What Seven Seas Original Pure Cod Liver Oil capsules are and what are they used for

Seven Seas Original Pure Cod Liver Oil Capsules provide a rich source of vitamins A, D and E and the unsaturated fatty acids EPA and DHA which are essential dietary components. It is a traditional remedy for the relief of muscular pains, joint pains and stiffness. It can be used in children and adults with poor dietary status and in the treatment of combined vitamins A, D, and E deficiencies.

DO NOT TAKE Seven Seas Original Pure Cod Liver Oil Capsules:

•    If you know you are allergic to any of the ingredients of this medicine (see ingredients section)

•    If you are receiving medical treatment for having too much vitamin A, D, E or Calcium in your blood

•    If you are taking thiazide diuretics (water tablets), oestrogen-containing contraceptives (the 'pill'), or with other vitamin A, D and E containing supplements or fish oils.

•    If you are pregnant, likely to become pregnant or breast feeding - except on the advice of a doctor or antenatal clinic

If any of these conditions apply to you, please discuss your treatment with your doctor or pharmacist before taking this medicine.

YOU MUST BE especially careful, tell your doctor or pharmacist if:

•    If you have asthma which is triggered by aspirin

•    If you have a bleeding disorder such as haemophilia (problems with blood clotting), if you are taking any medicines for blood clotting (e.g. warfarin), or you are taking aspirin or cephalosporin (an antibiotic)

•    If you suffer from liver problems

•    You are taking any other medicines including ones you have bought yourself as well as those you have on prescription from your doctor.

How to take

For oral use. Not recommended for children under 6 years.

Do not exceed the recommended dose

The capsules should be swallowed with a drink of water.

Dosage

Adults and children over 6 years

As a dietary supplement (to help keep joints pain free and supple).

Take 1 - 2 capsules three times a day.

If you are pregnant, likely to become pregnant or breast feeding:

Take 1 capsule three times a day.

For mild to moderate vitamin deficiency

Take 1 - 3 capsules three times a day, depending on the severity of the condition. It is usual to take this medicine for 2 weeks to 2 months or until your vitamin deficiency state is corrected.

If you take more of this medicine than you should, speak to your doctor or pharmacist straightaway. Take your medicine or the pack with you. If you miss a dose don't worry, do not take a double dose, continue with your usual dose at the next due time. If your symptoms persist or you have any questions about taking this medicine, talk to your doctor or pharmacist.

Possible side effects

Like all medicines Seven Seas Original Pure Cod Liver Oil Capsules can sometimes cause side effects but not everyone will get them. Seven Seas Original Pure Cod Liver Oil Capsules can sometimes cause nausea (feeling sick), vomiting (being sick), fishy after-taste, wind, skin reactions (e.g. eczema, acne and rash), abdominal pain, constipation, diarrhoea and a slight increase in liver enzymes if you have high levels of fat in the blood (hypertriglyceridaemia). If you experience any side effects or your symptoms persist tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

How to store

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

Keep in the outer container in order to protect from light and direct heat. Do not use after the expiry date shown on the bottle and carton. Please take any unused medicine back to your pharmacist.

This will help to protect the environment.

Ingredients

Each capsule contains 0.32 ml of Pure Cod Liver Oil containing eicosapentaenoic acid (EPA) 26 mg, docosahexaenoic acid (DHA) 24 mg, retinol (vitamin A) 670 IU, colecalciferol (vitamin D3) 67 IU, alpha tocopheryl acetate (vitamin E) 0.3 IU. The other ingredients are gelatine, glycerine and purified water.

The above noted vitamins and fatty acids are essential for building resistance to infections such as coughs and colds, healthy hair, skin and nails, good vision and strong bones.

Seven Seas Original Pure Cod Liver Oil Capsules are purified using Ocean Gold® refining technology.

Product Licence Holder and Manufacturer: Seven Seas Ltd., Hedon Road, Marfleet, Hull, HU9 5NJ, UK.

PL 01932/0259

This label was last revised: October 2013