FDA records indicate that there are no current recalls for this drug.
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Piper Nigrum E Fruct. 6 Special Order Recall
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Questions & Answers
Side Effects & Adverse Reactions
Only for use in the nose. Do not spray into your eyes or mouth.
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- in children under 4 years of age
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- To treat asthma
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- If you have an injury or surgery to your nose that is not fully healed
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- If you have ever had an allergic reaction to this product or any of the ingredients
have or had glaucoma or cataracts
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- medicine for HIV infection (such as ritonavir)
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- a steroid medicine for asthma, allergies or skin rash
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- ketoconazole pills (medicine for fungal infection)
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- the growth rate of some children may be slower
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- Stinging or sneezing may occur for a few seconds right after use
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- Do not share this bottle with anyone else as this may spread germs
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- Remember to tell your doctor about all the medicines you take, including this one
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- you have, or come into contact with someone who has, chicken pox, measles or tuberculosis
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- your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection.
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- you get a constant whistling sound from your nose. This may be a sign of damage inside your nose.
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- you get an allergic reaction to this product. Seek medical help right away.
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- you get new changes to your vision that develop after starting this product
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- you have severe or frequent nosebleeds
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
- •
- in children under 4 years of age
- •
- To treat asthma
- •
- If you have an injury or surgery to your nose that is not fully healed
- •
- If you have ever had an allergic reaction to this product or any of the ingredients
have or had glaucoma or cataracts
Ask a doctor or pharmacist before use if you are taking- •
- medicine for HIV infection (such as ritonavir)
- •
- a steroid medicine for asthma, allergies or skin rash
- •
- ketoconazole pills (medicine for fungal infection)
- •
- you have, or come into contact with someone who has, chicken pox, measles or tuberculosis
- •
- your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection.
- •
- you get a constant whistling sound from your nose. This may be a sign of damage inside your nose.
- •
- you get an allergic reaction to this product. Seek medical help right away.
- •
- you get new changes to your vision that develop after starting this product
- •
- you have severe or frequent nosebleeds
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
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- nasal congestion
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- runny nose
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- sneezing
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- itchy nose
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- itchy, watery eyes
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Piper Nigrum E Fruct. 6 Special Order Manufacturers
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Uriel Pharmacy Inc.
Piper Nigrum E Fruct. 6 Special Order | Glaxosmithkline Consumer Healthcare Lp
• read the Quick Start Guide for how to: • prime the bottle • use the spray • clean the spray nozzle • shake gently before each use • use this product only once a day • do not use more than directedADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER
• Week 1- use 2 sprays in each nostril once daily • Week 2 through 6 months- use 1 or 2 sprays in each nostril once daily, as needed to treat your symptomsCHILDREN 4 TO 11 YEARS OF AGE
• the growth rate of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. • an adult should supervise use • use 1 spray in each nostril once dailyCHILDREN UNDER 4 YEARS OF AGE
• do not use
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