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Drug Facts
Maxichlor Peh Dm
FDA Label NDC 58605-103
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 Maxichlor Peh Dm (NDC 58605-103). 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, when using this product, stop use and ask a doctor if, 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 |
|---|---|
| Chlorpheniramine Maleate 4 mg | Antihistamine |
| Dextromethorphan HBr 18 mg | Cough Suppressant |
| Phenylephrine HCl 10mg | 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 associated with a cold
- alleviates cough to help you sleep
- non narcotic cough suppressant for relief of cough
- itchy, watery eyes
- nasal congestion
- runny nose
- sneezing
- itching of the nose and throat
Warnings
- Do not exceed recommended dosage.
- a persistent cough may be a sign of a serious condition.
Do Not Use This Product
- If you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains 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 where cough is accompanied by excessive phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor before use if you are taking sedatives or tranquilizers
When Using This Product
- excitability may occur, especially in children
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
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. These could be signs 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 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 6 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 3 tablets in 24 hours, or as directed by a doctor |
| Children under 6 years of age: | Consult a doctor. |
Inactive Ingredients
Magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions Or Comments?
Call (352)754-8587
Principal Display Panel - 4 Mg/18 Mg/10 Mg Tablet Bottle Label
NDC 58605-103-01
100 Tablets
Maxichlor PEH DM
Antihistamine • Cough Suppressant
Nasal Decongestant
Each tablet contains:
Chlorpheniramine Maleate 4 mg
Dextromethorphan HBr 18 mg
Phenylephrine HCl 10 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 (4 mg/18 mg/10 mg Tablet Bottle Label)
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