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Drug Facts
Distributed by: Nivagen Pharmaceuticals, Inc
Sacramento, CA 95827 USA
Customer Service Number: 1-877-977-0687
Nivanex Dmx
FDA Label NDC 75834-040
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nivagen Pharmaceuticals, Inc. for the product Nivanex Dmx (NDC 75834-040). 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 other, otc - purpose, uses, warnings, do not use this product, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy 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 Tablet) | Purpose |
|---|---|
| Dextromethorphan HBr 15 mg | Cough Suppressant |
| Guaifenesin 380 mg | Expectorant |
| Phenylephrine HCl 10 mg | Nasal Decongestant |
Uses
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- cough due to minor throat and bronchial irritation
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- nasal congestion
- reduces swelling of nasal passages
Warnings
Do not exceed recommended dosage.
Do Not Use This Product
- 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 lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- a cough that occurs with too much phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
- new symptoms occur
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Do not exceed recommended dosage.
| Adults and children 12 years of age and over | 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours. |
| Children 6 to under 12 years of age | 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours. |
| Children under 6 years of age | Consult a physician. |
Other Information
Store at controlled room temperature 15° - 30°C (59°-86°F).
Inactive Ingredients
D&C Yellow # 10, FD&C Yellow # 6, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate.
Principal Display Panel - 60 Tablet Bottle Label
NDC 75834-040-60
NIVAGEN
PHARMACEUTICALS
Nivanex DMX™
COUGH SUPPRESSANT • EXPECTORANT
NASAL DECONGESTANT
EACH TABLET CONTAINS:
Dextromethorphan HBr
15 mg
Guaifenesin
380 mg
Phenylephrine HCl
10 mg
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing
60 TABLETS
Principal Display Panel (60 Tablet Bottle Label)
* Please review the disclaimer below.
