What does warnings and precautions mean on a drug label?

The WARNINGS AND PRECAUTIONS section on a drug/biologics label is intended to indentify and describe adverse reactions and other potential safety hazards that are serious or otherwise clinically significant because they have implications for prescribing decisions or for patient management.

When should you not use a danger sign?

The signal word "DANGER" is to be limited to the most extreme situations. DANGER [signs] should not be used for property damage hazards unless personal injury risk appropriate to these levels is also involved. See more ANSI Warning Signs.

Which adverse reactions should be included in the warnings and precautions?

The following adverse reactions which should be included in the WARNINGS AND PRECAUTIONS sections are detailed in the FDA guidance: Laboratory Test Interference: This means that a lab test result is inaccurate because the drug interferes with the assay.

Can a warning sign be used instead of a caution sign?

• Warning: "may be used to represent a hazard level between "Caution" and "Danger," instead of the required "Caution" tag, provided that they have a signal word of "Warning," an appropriate major message, and otherwise meet the general tag criteria of paragraph (f) (4) of this section." See more OSHA Caution Signs.

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Jeanie Rub 3401 Owner's Manual Massager for Professional & Home UseJeanie Rub®Jeanie Rub® Owner’s ManualCUSTOMER SUPPORTPHONE: 1 800 365 3047EMAIL: [email protected] : 1 715 294 2622POSTAL MAIL: Core Products International, Inc.ATTN: Customer Service808 Prospect AvenueOsceola, WI 54020-9950PRO-3401.V7.2014.0722©2014 Core ...

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Frequently Asked Questions

What does warnings and precautions mean on a drug label?

The WARNINGS AND PRECAUTIONS section on a drug/biologics label is intended to indentify and describe adverse reactions and other potential safety hazards that are serious or otherwise clinically significant because they have implications for prescribing decisions or for patient management.
When should you not use a danger sign?

The signal word "DANGER" is to be limited to the most extreme situations. DANGER [signs] should not be used for property damage hazards unless personal injury risk appropriate to these levels is also involved. See more ANSI Warning Signs.
Which adverse reactions should be included in the warnings and precautions?

The following adverse reactions which should be included in the WARNINGS AND PRECAUTIONS sections are detailed in the FDA guidance: Laboratory Test Interference: This means that a lab test result is inaccurate because the drug interferes with the assay.
Can a warning sign be used instead of a caution sign?

• Warning: "may be used to represent a hazard level between "Caution" and "Danger," instead of the required "Caution" tag, provided that they have a signal word of "Warning," an appropriate major message, and otherwise meet the general tag criteria of paragraph (f) (4) of this section." See more OSHA Caution Signs.