FDA Label for Niaflu
View Indications, Usage & Precautions
- 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,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- DIST. BY/ POR:
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Niaflu Product Label
The following document was submitted to the FDA by the labeler of this product Pharmadel Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients And Purposes
.
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
* Please review the disclaimer below.
