P - Product example Solution 10%
3rd
!

Brand Equivalent

Letairis® Tablets

Therapeutic Area

First aid

Product type

Solution

DIN

172944

Description

Active Ingredient

Fentanyl Citrate

Description

For coughing, colds and nasal congestion accompanied by fever and pain - for treatment day and night.

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Colours and sizes may differ from the example.
3rd
!

Product Details

Strength

50 mg

Size

115 mL 500 mL

Launch date

5/1/2021

Imprint code

TEVA/7271

Rating

LO

How does this medication work? What will it do for me?

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A generic medicine is a medicine that is an This combination product contains three medications: codeine, pheniramine, and guaifenesin. Codeine belongs to the group of medications called narcotic analgesics and cough suppressants. It works by blocking pain signals that are sent out by the brain to various areas of the body and reduces cough by acting in the brain to dull the cough reflex.

How should I use this medication?

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The recommended dose for adults and adolescents over 12 years old is 10 mL (2 teaspoonsful) every 4 to 6 hours as needed. No more than 6 doses should be taken in a 24-hour period.

What form does this medication come in?

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Each 5 mL of cherry-flavored, clear, orange, syrupy liquid with a menthol odour contains 100 mg of guaifenesin, 7.5 mg of pheniramine maleate and 10 mg of codeine phosphate. Nonmedicinal ingredients: alcohol, artificial coloring and flavoring, caramel, citric acid, FD&C Yellow No. 6, glycerine, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate dehydrate, sodium cyclamate and sucrose. Alcohol: 4.1 % v/v. Sucrose: 45 %

What side effects are possible with this medication?

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Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

Are there any other precautions or warnings?

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Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abdominal conditions

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Codeine, like other narcotic medications may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you are scheduled for abdominal surgery or have an abdominal condition such as inflammatory or obstructive bowel disease, acute cholecystitis, or pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

What other drugs could interact?

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There may be an interaction between codeine - pheniramine - guaifenesin and any of the following: abiraterone acetate aclidinium alcohol amiodarone

Package Details

115 mL 500 mL

NDC

00093-7370-01

Product Materials

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Key

3rd

3rd party Product

GSL

General Sales List

PP

Patient Pack

!

Discontinued

CPP

Calender Patient Pack

P

Pharmacy Only

Teva UK Limited also distributes some third party products within our portfolio, these products are identified with a 3rd party icon. For further information on these third party products, please contact the relevant Marketing Authorisation (MA) holder. If you require further assistance, you can contact our Medical Information Service by email medinfo@tevauk.com, or call 0207 5407117.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the Patient Information Leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of a medicine


Storage

Store at room temperature between 15oC and 30°C.

Learn about our Therapeutic Areas

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More Information

What are generic medicines?

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A generic medicine is a medicine that is an equivalent substitute to a brand name drug. Generic medicines contain the same active ingredients as the original brand products, and are available in the same strengths and dosage forms as the originals. A generic drug must work the same way in your body and produce the same treatment result as the brand name drug 01.

Why are generic drug names different from the original drug names?

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All brand-name drugs have a generic name. The generic name often appears next to the brand name and is the active ingredient(s) in the medication. Regulators often require that generic drugs are given a different name than the brand-name drugs, in order to avoid confusion. Typically, the generic name of a medicine is based on the name of its active ingredient(s), whereas the names given to brand-name drugs are intended for marketing purposes. There are a few unique cases where the generic medicine may also have another name besides the active ingredient. Ask your pharmacist if you have any questions.

Are generic drugs safe?

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A generic drug is bioequivalent to the brand-name innovative drug and meets the same quality standards. The active ingredient, the content, the dosage form and the usage of a generic drug are similar to those of an innovative drug. Regulatory authorities review the safety of both brand and generic prescription drugs before they are approved for use in a country. They also continue to monitor safety of these medications after approval 02.

What does Bioequivalence mean?

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Bioequivalence demonstrates a similar profile of behavior of two products in the human body, in terms of the rate and extent of absorption of the active pharmaceutical ingredient from the gastrointestinal (GI) tract to the blood stream. Bioequivalence study is a regulatory requirement and is performed for all generic drugs to ensure their efficiency and safety.

For any questions

You can contact us at any time with your questions or remarks.

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How to get this product

Teva's generic medications are available in most pharmacies across the United States, though not all pharmacies carry the same Teva medications. To find out if your medication is available as a Teva generic, contact your local pharmacy. If the pharmacy doesn't regularly stock a certain medication from Teva, ask if it can be ordered for you at no additional cost.

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Reporting Side Effects


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Size

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Strength

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Active Ingredient

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Size

2 kg 4 kg

Strength

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Prior to use, consult the leaflet for the doctor/consumer.

Do not rely on the content and information to receive and/or provide medical treatment and it is not intended to replace a doctor/consumer brochure and/or consultation with a qualified doctor.

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Not all the products are available for all territories. Please check availability with Medis business development.

Page Last Updated: 04 February 2024

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