Frequently Asked Questions

Milk, infant formulas, breast milk, and dairy products all contain a complex sugar (disaccharide) called lactose. Lactase is the enzyme our bodies need to produce to break down the lactose in milk and dairy products into the simple sugars (monosaccharides) glucose and galactose. These can then be absorbed as part of the normal digestive process.

TLD has been shown to be an important factor in some babies with colic. A deficiency of lactase enzyme in the small intestine results in the inability of the body to fully digest the lactose. This causes undigested lactose in milk and dairy products to be broken down by bacterial activity in the bowel, which produces lactic acid and hydrogen gas and results in severe discomfort, bloating, and gas.

The baby may not yet be producing sufficient levels of lactase enzyme, because he or she was born with an immature digestive system. However, by the time the baby is 3 to 4 months old, his or her digestive system should have developed sufficiently to produce adequate levels of lactase enzyme for proper digestion of the infant’s breast milk or formula.

Colief^® is a dietary supplement, which is added to infant milk. The active ingredient in Colief^® is lactase, a safe, naturally occurring enzyme produced within the small intestine. Colief^® is not a medication.

The addition of Colief^® Infant Drops to the baby's usual milk compensates for a possible temporary lactase deficiency in the baby's digestive system. Colief^® Infant Drops added to a baby's usual milk greatly reduces the level of lactose by breaking it down into glucose and galactose before the baby is fed. Studies have shown that the hours of crying may be greatly reduced when a baby's usual milk is treated with Colief^®.

The only ingredients in Colief^® are lactase enzyme (which should be naturally present in a normal, developed digestive system), glycerol (or "glycerine"—which is also naturally present in the body as part of the process of converting fats to energy), and water. None of these ingredients has ever been shown to pose a risk to health.

Yes. Glycerol is derived from vegetable sources, and the lactase enzyme is derived from yeast.

Colief^® Infant Drops can safely be used from birth.

Colief^® Infant Drops can be used at every feeding until the baby is 3 to 4 months old, by which time the signs of colic should have disappeared. Colief^® can then be withdrawn gradually from use, first by halving the drops per feed, then using at alternative feeds, then one feed per day before complete withdrawal. If at any stage the signs of colic return, revert to previous dosage.

When babies begin taking milk treated with Colief^®, there may be change in stool pattern. The stools may then resemble those of a breastfed baby—looser and more frequent—even if formula feeding. If you are happy that the baby is otherwise well, gaining weight and urinating normally, there should be no cause for concern. If the drops seem to be working well, you might try reducing the number of drops used at each feed.

If you have any concerns regarding your baby's health, you should consult a health care professional as soon as possible.

Colief^® was tested at Cork University Hospital, Ireland, by Professor Kearney in the early 1990s to demonstrate that a lactose-reduced feed was effective in reducing infant colic. His results were presented to the Royal College of Pediatricians at its annual meeting in spring 1994 and published in the Journal of Human Nutrition and Dietetics in September 1998. These results were confirmed in a larger study recently completed at Guy’s Hospital, London, by Dr Dipak Kanabar and published in the Journal of Human Nutrition and Dietetics in October 2001.

Express a few tablespoons of breast milk into a sterilized container. Add 4 drops of Colief^®. Give this to the baby on a sterilized plastic spoon before initiating breastfeeding. Breast feed as normal.

If drops were given directly to the baby, the acid in the upper digestive tract would quickly change the nature of the enzyme and render Colief^® ineffective. However, mixing 4 drops of Colief^® with a little expressed foremilk* appears to protect the active ingredient, lactase enzyme. The foremilk preparation provides a lining to the baby’s upper digestive tract, mixing with the breast milk and working to reduce the lactose level of the milk.

We believe that in this form, the enzyme has an effective "working life" of approximately 30 minutes. Laboratory trials have shown that 4 drops of Colief^® in 3.38 fl oz of infant milk at body temperature will break down approximately 70% of the lactose in 30 minutes.

*Foremilk contains a concentration of the lactose in breast milk.

If you are feeding this frequently, you may find it convenient to express approximately half a cup of foremilk* and store this in a refrigerator. Pour a few tablespoons, warm it to body temperature, add Colief^®, and give this to your baby before each feeding.

If the feedings are small—say 1.7 fl oz each—you may be able to use only 2 drops of Colief^® per feeding. It is worth remembering that most of the lactose is concentrated in the foremilk at the beginning of every feeding.

*Foremilk contains a concentration of the lactose in breast milk.

Express a single serving of breast milk. While still at body temperature, pour it into a feeding bottle and add 4 drops of Colief^®, shaking occasionally. The breast milk will be ready to use after 30 minutes.

Yes, though the latest advice from health experts is that bottles should be prepared as and when required. The bottles should be prepared as normal and allowed to cool to body temperature (not hot, not cold). Add 2 drops of Colief^® per feeding and place them in a refrigerator for a minimum of 4 hours. Take the feedings from the refrigerator as required.

If prepared in advance, we recommend 12 hours as a maximum limit for keeping milk treated with Colief^®, even when stored in a refrigerator. After 4 hours, most of the lactose will be broken down and there will be little more activity thereafter. It is not good practice to keep prepared formula for too long, even in a refrigerator.

Option 1: Express a single feeding, and while still at body temperature, pour this into a suitable container. Add 2 drops of Colief^® and place the breast milk in a refrigerator for 4 hours. Then use as required or freeze for future use. Do not place the breast milk straight in the freezer after adding the drops.

Option 2: Take a single serving of frozen breast milk from the freezer, thaw and heat gently to body temperature. Then add 4 drops of Colief^® and use after 30 minutes.

Note: It is important to add Colief^® only to milk that is at body temperature: do not add the drops to milk that is either hot or cold. Also discard any milk that is unused once thawed. Do not refreeze.

Prepare the formula as per manufacturer’s instructions. Add 4 drops of Colief^® to the warm (not hot) formula. Wait 30 minutes, shaking the formula occasionally, then feed the baby as normal, making sure the formula is at the correct temperature. Discard any unused formula.

Warm the formula, add 4 drops of Colief^® to the warm (not hot) formula. Wait 30 minutes, shaking the formula occasionally, then feed the baby as normal, making sure the formula is at the correct temperature. Discard any unused formula.

Once opened, ready-made formula must be kept refrigerated and used according to the manufacturer’s instructions. Colief^® works best in warm milk. Colief^® should not be added to milk at refrigerator temperature.

There’s no point using Colief^® with soy or lactose-free formulas. These do not contain lactose, so Colief^® will have no active effect.

Yes. Goat’s-milk-based infant formula contains lactose the same as any other normal formula. Use Colief^® Infant Drops the same way as used with other formula.

Yes, though the latest advice from health experts is that bottles should be prepared as and when required. The bottles should be prepared as normal and allowed to cool to body temperature (not hot, not cold). Add 2 drops of Colief^® per feeding and place them in a refrigerator for a minimum of 4 hours. Take the feedings from the refrigerator as required and reheat before giving to the baby.

If prepared in advance, we recommend 12 hours as a maximum limit for keeping milk treated with Colief^®, even when stored in a refrigerator. After 4 hours, most of the lactose will be broken down and there will be little more activity thereafter. It is not good practice to keep prepared formula for too long, even in a refrigerator.

Not at refrigerator temperature. The drops work very slowly on milk that is already chilled. The ideal temperature for the enzymes to work properly is between room temperature and body temperature—neither too hot nor too cold. This is why we recommend that the drops be added when the formula is first prepared then allowed to cool to body temperature.

In the US, no prescription is necessary for the purchase of Colief^® because Colief^® is a dietary supplement, not a drug.

Right now, Colief^® is available exclusively at CVS/pharmacy^® and at CVS.com.

Unopened bottles of Colief^® should be stored in a cool, dry place below 77ºF. Once opened, Colief^® should be stored in a refrigerator, and the opened bottle discarded after 3 weeks. The bottle must not be frozen.