Drug Facts Label: How to Read the Drug Facts Label

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The U.S. Food and Drug Administration (FDA) requires all over-the-counter (OTC) medications to have a Drug Facts label. This label provides basic information about a drug’s ingredients, instructions for use, and important safety cautions and interactions. This information will help you to select the correct medication and to use it properly.

The Drug Facts label is only required for OTC drugs, and it is not used for dietary supplements, such as vitamins, minerals, and herbal remedies.

Always Read the Label

The FDA requires the labels on all OTC medicines to have information listed in the same order, to bearranged in a simple eye-catching, consistent style, and to contain words that are easy to understand.

Since you may be taking an OTC medication without seeing your doctor, it is important that you read and understand the information on the label. If you are not sure what the information means or you are concerned about interactions with other medications you are taking, talk to your pharmacist or doctor. If you have a problem with your vision, ask a friend or family member to read the label for you.

Tamper-Evident Packaging

Although not required by the FDA, many makers of OTC medications use tamper-evident containers for their products. This is to help protect you from possible criminal behavior.

The label on medications with tamper-evident packaging will have a statement on the package describing this safety feature, such as:

“TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL AROUND CAP IS BROKEN OR MISSING”

If you think the package has been tampered with in any way, do not buy the medication. Take it to the pharmacist, store manager, or clerk to make them aware of the damage.

What’s on the Drug Facts Label?

Active Ingredient
The active ingredient is the part of the medication that is responsible for the medication’s effect.

It is listed first on the label along with the amount or dose of medication in each pill or teaspoon of liquid. This section will also tell you the purpose of the medication.

A Dr. Mike Safety Tip: Do not take two medications with the same active ingredient at the same time unless recommended by your doctor or pharmacist.

Uses
This section of the drug label tells you for what symptoms and health conditions the FDA has approved for this medication to treat or prevent.

Warnings
This section of the drug label includes the following types of warnings:

  • When not to use the medication
  • Conditions that may require advice from your doctor before you use the medication
  • Possible interactions with other drugs and food
  • Possible side effects of the medication
  • When to stop taking the medication and when to contact a doctor
  • What to do if you are pregnant or breastfeeding
  • A warning to keep the medication out of a child’s reach

Directions
This section of the drug label tells you how much of the medication to take, how to take it, and how often to take it.

Moreover, the directions will tell you the correct method for using the medication for children and adults.

A Dr. Mike Safety Tip: Follow the directions carefully. If you take too little of the medication you may not have the desired effect and if you take too much of the medication you may have unpleasant side effects.

Other Information
This section of the drug label tells you how to store the medication and how much sodium, potassium, and calcium the product contains, if any.

Inactive Ingredients
This section of the drug label tells you about substances in the medication that are not intended to treat your symptoms or health condition. These substances may include colors, flavors, preservatives, and materials that bind the pill together. It is important that you be aware of these ingredients because they can cause allergic reactions in some people.

The Label May Also Tell You:

  • The expiration date or the date after which you should not use the medication
  • Lot number or batch code from the medication’s manufacturer to help identify the product
  • Name and address of the manufacturer, packer, or distributor
  • How much of the medication is in each package
  • What to do if you take an overdose on the medication

Example of a Drug Label

An example of a drug label using information from an aspirin bottle:

Active ingredient
(in each tablet)

Aspirin 325 mg

Purpose
Pain reliever/fever reducer

Uses
provides temporary relief of

  • headache
  • toothache
  • muscle pain
  • pain and fever of colds
  • menstrual pain
  • minor pain of arthritis

Warnings
Reye’s syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s syndrome, a rare but serious illness reported to be associated with aspirin.

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

Do not use if you are allergic to aspirin.

Ask a doctor before use if you have

  • asthma
  • stomach problems that persist or recur
  • ulcers
  • bleeding problems

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • anticoagulation (blood thinning)
  • diabetes
  • gout
  • arthritis

Stop using and ask a doctor if

  • pain worsens or lasts more than 10 days
  • fever worsens or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • ringing in the ears or loss of hearing occurs

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

  • adults: 1 to 2 tablets with water. dosage may be repeated every 4 hours, not to exceed 12 tablets in 24 hours.
  • children under 12: consult a doctor.

Other Information
Store at controlled room temperature 15°-30°C (59°-86°F)

Inactive ingredients
hypromellose, starch, titanium dioxide

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