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Drug Facts
Maximum Strength Severe Congestion And Cough Liquid
FDA Label NDC 21130-738
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Maximum Strength Severe Congestion And Cough (NDC 21130-738). 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, when using this product, 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 20 mL) | Purposes |
|---|---|
Dextromethorphan HBr 20 mg | Cough suppressant |
Guaifenesin 400 mg | Expectorant |
Phenylephrine HCl 10 mg | Nasal decongestant |
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▪ nasal congestion due to a cold
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
▪ heart disease▪ high blood pressure▪ thyroid disease▪ diabetes▪ trouble urinating due to an enlarged prostate gland▪ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema▪ cough that occurs with too much phlegm (mucus)
When Using This Product
▪ do not use more than directed
Stop Use And Ask A Doctor If
▪ nervousness, dizziness or sleeplessness occur▪ symptoms do not get better within 7 days or occur with fever▪ cough comes back, or occurs with rash or persistent headache. These could be signs of a serious condition.
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. (1-800-222-1222)
Directions
▪ do not take more than 6 doses in any 24-hour period▪ measure only with dosing cup provided▪ do not use dosing cup with other products▪ dose as follows or as directed by a doctor▪ mL = milliliter▪ adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours.▪ children under 12 years of age: Do not use.
Other Information
▪ each 20 mL contains: sodium 8 mg▪ low sodium▪ store at room temperature▪ do not refrigerate
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-866-467-2748
Principal Display Panel
NDC 21130-738-06
Compare to Mucinex® Fast- Max® Maximum Strength Severe Congestion & Cough Active Ingredients*
Maximum Strength
Severe Congestion & Cough
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant
- Control Cough
- Relieves Nasal and Chest Congestion
- Thins & loosens mucus
For Ages 12+
6 FL OZ (180 mL)
Tamper evident: do not use if printed seal under cap is broken or missing.
*This product is not manufactured or distributed by RB Health (US) LLC, the distributor of Mucinex® and Fast-Max® Maximum Strength Severe Congestion & Cough.
Distributed by:
Severe Congestion And Cough Max Strength (Mucinex 01)
* Please review the disclaimer below.
