Page 118 - Microsoft Word -Cow Book 10-06-09 final update.doc

LABELING GUIDANCE

I. Drug Labeling Requirements for OTC, Rx and Extra Label Use.

A. Over-the-counter (OTC) drugs used as labeled must:

1. Bear a manufacturer's label with the active ingredient(s) and
indications for use (which must include dosage, route of
administration and duration of therapy) in LACTATING dairy
cattle including meat and milk withholding times,

OR

2. Bear a manufacturer's label with the active ingredients and
indications for use in NON-LACTATING cattle.

3. No other additional veterinary label is required when such
OTC drugs are used according to label directions.

4. Instructions for use must include dosage, route of
administration and duration of therapy.

B. Prescription (Rx) drugs used as labeled must:

1. Bear the prescribing veterinarian's name and address in addition
to the manufacturer's label which must include the active ingredi-
ent(s) and indications for use (dosage, route of administration
and duration of therapy) in LACTATING dairy cattle including
meat and milk withholding times,

OR

2. Bear the prescribing veterinarian's name and address in addition
to the manufacturer's label which must include the active ingredi-
ent(s) and indications for use in NON-LACTATING cattle,

REMEMBER - the prescription legend reads "Caution: Federal (USA) Law
restricts this drug to use by or on the order of a licensed veterinarian."

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