FDA Label for Maxichlor Peh Dm

View Indications, Usage & Precautions

Maxichlor Peh Dm Product Label

The following document was submitted to the FDA by the labeler of this product Mcr American Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



Active Ingredients (in each tablet)Purpose
Chlorpheniramine Maleate 4 mgAntihistamine
Dextromethorphan HBr 18 mgCough Suppressant
Phenylephrine HCl 10mgNasal 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.


* Please review the disclaimer below.