MAXICHLOR PEH DM- chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet

Maxichlor PEH DM by

Drug Labeling and Warnings

Maxichlor PEH DM by is a Otc medication manufactured, distributed, or labeled by MCR American Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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.

INGREDIENTS AND APPEARANCE

MAXICHLOR PEH DM 
chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58605-103
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	18 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
Magnesium Stearate (UNII: 70097M6I30)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	OVAL	Size	16mm
Flavor		Imprint Code	MAXICHLOR;PEH;DM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58605-103-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2018
2	NDC: 58605-103-20	20 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	04/01/2018

Labeler - MCR American Pharmaceuticals, Inc. (783383011)

Establishment
Name	Address	ID/FEI	Business Operations
MCR American Pharmaceuticals, Inc.		783383011	MANUFACTURE(58605-103)