Active Ingredients And Purposes
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Niaflu Capsule, Liquid Filled
FDA Label NDC 55758-507
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Niaflu (NDC 55758-507). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients and purposes, otc - purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each softgel) | Purposes |
| Dextromethorphan HBr 20 mg ...... | Cough suppressant |
| Guaifenesin 400 mg ..... | Expectorant |
Uses
Temporarily alleviates common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- helps loosen phlegm (mucus) and thin bronchial secretions to
- drain bronchial tubes
- make coughs more productive
Warnings
Do Not Use
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
- a cough that is accompanied by excessive phlegm (mucus)
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
Stop Use And Ask A Doctor If
- cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than 6 softgels in a 24 hour period
| Age | Dose |
| adults and children 12 years and older | 1 softgel, every 4 hours |
| children under 12 years | do not use |
Other Information
- store between 68-77°F (20-25°C)
- do not use if blister pack is torn or punctured
Inactive Ingredients
gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone k30, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide, water
Questions Or Comments?
+1-866-359-3478(M-F) 9 AM - 5 PM EST or www.pharmadel.com
Dist. By/ Por:
PHARMADEL LLC
New Castle, DE, 19720
+1-866-359-3478
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