Otc - Active Ingredient
Drug Facts
Active ingredients
(in each 20 mL)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Severe Congestion And Cough Max Liquid
FDA Label NDC 76281-517
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aptapharma Inc. for the product Severe Congestion And Cough Max (NDC 76281-517). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Dextromethorphan HBr Cough suppressant
Guaifenesin Expectorant
Phenylephrine Nasal Decongestant
Indications & Usage
Uses
● helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
● temporarily relieves these symptoms occurring with a cold:
● cough due to minor throat and bronchial irritation
● nasal congestion
Warnings
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.
• For children under 12 years of age
Ask a doctor before use if you have ● heart disease ● thyroid disease ● high blood pressure ● diabetes
● trouble urinating due to an enlarged prostate gland ● cough that lasts or is chronic 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 are accompanied by a
fever ● cough comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.
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.
Dosage & Administration
Directions
• take only as recommended
• use dosage cup
• mL =milliliter
• do not take more than 6 doses in any 24-hour period
| Adults & children 12 years and older | 20 mL every 4 hours |
| Children under 12 years of age | Do not use |
Other Safety Information
Other information
• each 20 mL contains: sodium 10 mg
• dosage cup provided
• store between 15-30°C (59-86°F)
• do not refrigerate
Inactive Ingredient
Inactive ingredients
Anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, flavors, glycerin, propylene glycol, propyl
gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Otc - Questions
Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944
Maximum Strength Max Severe Congestion & Cough
AP SAFE® NDC 76281-517-25
Compare to Mucinex® FAST-MAX™ Severe Congestion
& Cough Active ingredients*
Maximum Strength
Max Severe Congestion & Cough
Dextromethorphan HBr/
Cough Suppressant
Guaifenesin /Expectorant
Phenylephrine HCI / Nasal Decongestant
Congestion& Cough
Relief of:
• Cough
• Thins & Loosens Mucus
• Nasal & Chest Congestion
Adults- For Ages 12 and over
6 FL OZ ( 177 mL)
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110
This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAX™ Severe
Congestion & Cough.
res
* Please review the disclaimer below.
