Label: MAXICHLOR PEH DM- chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 58605-103-01, 58605-103-20 - Packager: MCR American Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 15, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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
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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
- Questions or Comments?
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PRINCIPAL DISPLAY PANEL - 4 mg/18 mg/10 mg Tablet Bottle Label
NDC 58605-103-01
100 TabletsMaxichlor PEH DM
Antihistamine • Cough Suppressant
Nasal DecongestantEach tablet contains:
Chlorpheniramine Maleate 4 mg
Dextromethorphan HBr 18 mg
Phenylephrine HCl 10 mgStore 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.
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INGREDIENTS AND APPEARANCE
MAXICHLOR PEH DM
chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tabletProduct 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)