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Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th Court, Suite 1901
Miami, FL 33156-3178
Made in USA
www.vivunt.live
Axiv Dm Max Liquid
FDA Label NDC 82706-024
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vivunt Pharma Llc for the product Axiv Dm Max (NDC 82706-024). 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, do not use, ask a doctor before use if you have, otc - when using, 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 20 mL) | Purposes |
|---|---|
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Guaifenesin 400 mg | Expectorant |
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
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
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Otc - When Using
Do not exceed recommended dosage.
Stop Use And Ask A Doctor If
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. 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 doses in any 24-hour period
- this adult strength product is not intended for use in children under 12 years of age
- measure only with dosing cup provided
- keep dosing cup with product
- mL = milliliter
| age | dose |
| adults and children 12 years of age and older | 20 mL every 4 hours |
| children under 12 years of age | do not use |
Other Information
- each 20 mL contains: sodium 7 mg
- store at 15-30°C (59-86°F)
- do not refrigerate
Inactive Ingredients
Citric acid, FD&C Blue #1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.
Principal Display Panel
Compare to Maximum Strength Mucinex® Fast-Max®
NDC 82706-024-01
AXIV - DM MAX
Cough Relief
Cough Suppressant
Expectorant
Maximum Strength
Non-Drowsy
Dextromethorphan HBr
Guaifenesin
6 FL OZ (177 mL)
* Please review the disclaimer below.
