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Drug Facts
Maxifed
FDA Label NDC 58605-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mcr American Pharmaceuticals, Inc. for the product Maxifed (NDC 58605-101). 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, 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 immediate-release tablet) | Purpose |
|---|---|
| Guaifenesin 360 mg | Expectorant |
| Pseudoephedrine HCl 60 mg | Nasal Decongestant |
Uses
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:
- helps loosen phlegm and thin bronchial secretions to make coughs more productive
- nasal congestion
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
Warnings
- Do not exceed recommended dosage.
- a persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
Stop Use And Ask A Doctor If
- nervousness, dizziness or sleeplessness 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 accidental overdose, seek professional help or contact a Poison Control Center immediately.
Directions
Do not exceed recommended dosage.
| Adults and children 12 years of age and over: | 1 tablet by mouth every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor. |
| Children 6 to under 12 years of age: | ½ tablet by mouth every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor. |
| Children 2 to under 6 years of age | consult a doctor |
Inactive Ingredients
Magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions Or Comments?
Call 1-352-754-8587
Principal Display Panel - 360 Mg/60 Mg Tablet Bottle Label
NDC 58605-101-01
100 tablets
Maxifed
Expectorant • Nasal Decongestant
Each immediate-release tablet contains:
Guaifenesin 360 mg
Pseudoephedrine HCl 60 mg
Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature].
Tamper evident by foil seal under cap. Do not use if foil seal is broken
or missing.
Principal Display Panel (360 mg/60 mg Tablet Bottle Label)
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