Benz PEARLS

Benz PEARLS is a medication taken orally to suppress coughs. It has an anesthetic (numbing) action similar to that of benzocaine and "numbs" the stretch sensors in the lungs. It is the stretching of these sensors with breathing that causes the cough. Benz PEARLS begins to work within 15 to 20 minutes, and its effects last for approximately 3 hours. Benz PEARLS is unrelated to narcotics such as codeine which are frequently used to suppress coughs. (Another frequently used cough suppressant, dextromethorphan, which is found in many over-the-counter cough and cold preparations, is a derivative of the narcotics.) Benz PEARLS was approved by the FDA in 1958.

Benz PEARLS is used to relieve coughs due to colds or influenza (flu). It is not to be used for chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm with the cough.

Benz PEARLS relieves cough by acting directly on the lungs and the breathing passages. It may also act on the cough center in the brain.

Benz PEARLS is available only with your doctor's prescription.

Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benz PEARLS Capsules should be swallowed whole. Benz PEARLS Capsules are not to be broken, chewed, dissolved, cut or crushed.

How supplied

Benz PEARLS capsules USP, 100 mg are light yellow-colored, round-shaped soft gelatin capsules, imprinted with “Z” containing pale yellow-colored clear viscous liquid and are supplied as follows:

NDC 65841-614-01 in bottle of 100 capsules

NDC 65841-614-05 in bottle of 500 capsules

Benz PEARLS capsules USP, 200 mg are light yellow-colored, round-shaped soft gelatin capsules, imprinted with “β” containing pale yellow-colored clear viscous liquid and are supplied as follows:

NDC 65841-615-01 in bottle of 100 capsules

Store at 20° - 25°C (68° - 77°F).

Dispense in a tight, light-resistant container.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Revised: 11/03/2011

See also:
What is the most important information I should know about Benz PEARLS?

You should not use this medication if you are allergic to Benz PEARLS or topical numbing medicines such as tetracaine or procaine (found in some insect bite and sunburn creams).

Never suck or chew on a Benz PEARLS capsule. Swallow the pill whole. Sucking or chewing the capsule may cause your mouth and throat to feel numb or cause other serious side effects.

Serious side effects of Benz PEARLS include choking feeling, chest pain or numbness, feeling like you might pass out, confusion, or hallucinations. Some of these side effects may result from chewing or sucking on a Benz PEARLS capsule.

Do not give this medication to a child younger than 10 years old without medical advice. An overdose of Benz PEARLS can be fatal to a child.

Use Benz PEARLS as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Benz PEARLS by mouth with or without food.
• Swallow Benz PEARLS whole. Do not break, crush, chew, dissolve, or suck on Benz PEARLS before swallowing.
• If you miss a dose of Benz PEARLS, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Benz PEARLS.

Use: Labeled Indications

Cough: Symptomatic relief of cough

See also:
What other drugs will affect Benz PEARLS?

There are no known drug interactions with Benz PEARLS.

See also:
What are the possible side effects of Benz PEARLS?

Applies to Benz PEARLS: oral capsule, oral capsule liquid filled

As well as its needed effects, Benz PEARLS (the active ingredient contained in Benz PEARLS) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Benz PEARLS, check with your doctor immediately:

Rare

• Confusion
• difficult breathing
• difficulty with speaking
• seeing things that are not there
• shortness of breath
• tightness in the chest
• wheezing

If any of the following symptoms of overdose occur while taking Benz PEARLS, get emergency help immediately:

Symptoms of overdose:

• Change in consciousness
• convulsions (seizures)
• loss of consciousness
• no blood pressure or pulse
• restlessness
• shakiness in the legs, arms, hands, or feet
• stopping of the heart
• trembling or shaking of the hands or feet
• unconsciousness

Minor Side Effects

Some Benz PEARLS side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common or rare:

• Burning sensation in the eyes
• constipation
• dizziness (mild)
• drowsiness (mild)
• headache
• itching
• nausea or vomiting
• skin rash
• stuffy nose

Benz PEARLS is a non-narcotic oral antitussive (cough suppressant) drug which works by anesthetizing the tissues of the lungs and pleura responsible for the cough reflex. It is chemically related to other ester anesthetics such as procaine. It has an anesthetic (numbing) action similar to that of benzocaine and "numbs" the stretch sensors in the lungs. It is the stretching of these sensors with breathing that causes the cough. It was approved by the FDA in 1958