DENTINOX INFANT COLIC DROPS Oral suspension Ref.[49653] Active ingredients: Simethicone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Dendron Brands Limited, 94, Rickmansworth Road, Watford, Hertfordshire, WD18 7JJ, United Kingdom

4.1. Therapeutic indications

For the gentle relief of wind and griping pains in infants, caused by the accumulation of ingested air. Facilitates eructation. Can be used from birth onwards.

4.2. Posology and method of administration

2½ ml (one measured dose of the syringe) with or after each feed. May be added to the infant’s bottle or given orally directly from the syringe. Maximum 6 doses per day. For infants can be used from birth onwards.

4.9. Overdose

From the literature it would appear that all the silicone will be excreted unchanged and that there was no increase of urinary silicate output or of absorption of the silicone.

It was concluded that the Activated Dimeticone carried no significant carcinogenic hazard, and that no other significant toxic effect attributable to Activated Dimeticone has been observed.

Overdosage may prove a problem with diabetics because of the sugar content.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Pack size 100ml:

100ml – HDPE round bottle with a jay cap tamper evident closure, with 2.5ml oral dosing syringe.

Pack size 2.5ml:

Sample sachets:

40gsm craft paper, 10 gsm polyethylene, 8gsm aluminium foil and 30gsm surlyn.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

After use, rinse the syringe with warm water and dry.

Not suitable for steam sterilisation.

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