Vitacee Drops

VITACEE® DROPS AND SYRUPS

VITACEE® DROPS NAFDAC REG NO: 04-1848

VITACEE® SYRUPS NAFDAC REG NO: 3170

1. QUALITATIVE AND QUANTITATVE COMPOSITION

(INGREDIENTS)

For drops, each 1ml contains 100mg of ascorbic acid. For syrups, each 5ml contains 100mg of ascorbic acid.

1. PHYSICAL/CHEMICAL CHARACTERISTICS

VITACEE® DROPS AND SYRUPSis a unique formulation that has pleasant taste, flavour and well stabilized for the use of infants, children and adults.

1. MANUFACTURING METHOD COMPLYING WITH GMP GUIDELINES

Good Manufacturing Practices (GMP) and guidelines are perfectly observedVITACEE® DROPS AND SYRUPSare manufactured in a very high hygienic environment.

1. INFORMATION ABOUT PACKAGING MATERIALS(LABELS, JACKETS ETC)

Vitacee is available in 15ml for drops, and 100ml packs for syrups.It is packed with a graduated dropper in the jacket to be used for dispensing the drug in drops.The pictures of the jackets are seen above.

1. THERAPEUTIC INDICATIONS/REASONABLY FORSEEABLE USE

• Treatment and prevention of scurvy in bottle-fed infants and growing children.
• Essential for the synthesis of collagen, some chemical transmitters and for energy conversion.
• Promotes wound healing and against infections.
• Good for treatment and prevention of common colds.
• Promotes general metabolic processes in the body.
• Regular intake by infants and growing children is very important as the human body does not naturally produce vitamin C.

1. DOSAGE/METHOD OF ADMINISTRATION/ THE EXPOSED(TARGETED POPULATION)

Vitacee® drops and syrups are to be taken orally with the dropper or measuring cup provided in the pack.

Generally, infants require 40-50mg/day of vitamin C.

For infants: 1-2drops three times daily

For children up to 3 years: 2-3 drops three to four times daily

Children above 3 years: 2.5ml or 5ml daily

Children 6-12years: 5ml two times daily

Children above 12 years and adults: 5ml two or three times daily.

Doses may be adjusted according to the doctor’s prescription.

1. WARNINGS AND PRECAUTIONS FOR USE

• The stated dose must be respected
• Vitamin C may affect blood sugar levels. Caution is advised in patients with diabetes or hypoglycemia, and in those taking drugs, herbs, or supplements that affect blood sugar. Blood glucose levels may need to be monitored by a qualified healthcare professional, including a pharmacist. Medication adjustments may be necessary.
• If any abnormal reaction is noticed please stop the use and seek your doctor or pharmacist advice.
• Use the dropper provided with the product, do not use spoon
• Use the graduated measuring cup provided with the product.

1. PREGNANCY/ LACTATION

Vitamin C intake from food is generally considered safe during pregnancy. It is not clear if vitamin C supplementation in amounts exceeding Dietary Reference Intake recommendations is safe or beneficial during pregnancy. There are rare reports of scurvy due to tolerance or resistance in infants born to mothers taking extra vitamin C throughout the pregnancy. The data are too few to say if vitamin C supplementation alone or combined with other supplements is beneficial during pregnancy. Preterm birth may increase with vitamin C supplementation.

Vitamin C is present in breast milk. Vitamin C intake from food is generally considered safe in breastfeeding mothers. Limited research suggests that vitamin C in breast milk may reduce the risk of developing childhood allergies. It is not clear if vitamin C supplementation in amounts exceeding Dietary Reference Intake recommendations is safe or beneficial during breastfeeding.[1]

1. OVERDOSE(SIGNS,SYMPTOMS AND TREATMENT)

VITACEE® DROPS AND SYRUPS are usually welltolerated. In case of any abnormal reaction, the doctor or pharmacist should be consulted.

1. TOXICOLOGICAL PROFILE OF SUBSTANCES(IRRITATIONS ETC)

Although it's prudent not to take mega-doses of vitamin C when you're pregnant. Some studies show that taking too much vitamin C in the form of supplements during pregnancy may increase the risk of preterm birth, and there are rare reports of babies born with scurvy (a severe vitamin C deficiency) to expectant moms who took vitamin C supplements. Excessivevitamin C can also upset your stomach.

1. SHELF LIFE/STORAGE

• Do not store above 250C
• Protectfrom light
• Keep this product tightly closed in its original pack after each use
• Keep this product out of the reach of children
• Do not use the product after the expiry date.
• Shelf life is two years after date of production

5.12 FREQUENTLY ASKED QUESTIONS

• Why does it have an alcoholic smell after a long time?

It occurs as a result of bad storage and exposure to light.This causes the ascorbic acid to ferment.

• Why is the packaging outdated?

For some times now the company has not undergone any  seasonal improvement in repackaging/rebranding with regards to current competitors on most of its products.