MAXICHLOR PEH DM- chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet 
MCR American Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Maxichlor PEH DM

Drug Facts

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:

Warnings

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

If pregnant or breast-feeding, ask a health professional before use.

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
MAXICHLOR PEH DM 
chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58605-103
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE18 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
Magnesium Stearate (UNII: 70097M6I30)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize16mm
FlavorImprint Code MAXICHLOR;PEH;DM
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58605-103-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2018
2NDC:58605-103-2020 in 1 BLISTER PACK; Type 0: Not a Combination Product04/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/01/2018
Labeler - MCR American Pharmaceuticals, Inc. (783383011)
Establishment
NameAddressID/FEIBusiness Operations
MCR American Pharmaceuticals, Inc.783383011MANUFACTURE(58605-103)

Revised: 3/2018
Document Id: 9f6e84e3-dba2-4c15-bdcf-bc2c0450f1d9
Set id: 70bb5a77-8a9b-4794-93e7-90c21482fb8b
Version: 1
Effective Time: 20180315
 
MCR American Pharmaceuticals, Inc.