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Maxiphen

MCR American Pharmaceuticals, Inc.

Maxiphen


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients
(in each immediate-release tablet)
Purpose
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal Decongestant

Maxiphen Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:

  • helps loosen phlegm and thin bronchial secretions to make coughs more productive
  • nasal congestion
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

Warnings

  • Do not exceed recommended dosage.
  • a persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor

Do not use

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an 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 if cough is accompanied by excessive phlegm
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor before use if you are taking sedatives or tranquilizers

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness 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: 1/2 tablet by mouth every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor

Inactive ingredients

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Question? Comments?

Call 1-352-754-8587

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 58605-0422-01

100 tablets

Maxiphen

Expectorant • Nasal Decongestant

Each immediate-release tablet contains:
Guaifenesin 400 mg
Phenylephrine HCl 10 mg

This bottle is not to be dispensed to consumer.

Dispense in a tight light-resistant container with
a child-resistant cap.

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.

MCR American

Maxiphen

Maxiphen

GUAIFENESIN and Phenylephrine Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58605-422
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Guaifenesin GUAIFENESIN 400 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
MAGNESIUM STEARATE
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
WHITE 16 mm MAXIPHEN OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58605-422-01 100 in 1 BOTTLE, PLASTIC
2 NDC:58605-422-02 20 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2008-03-31


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Be sure to consult your doctor before taking any medication!
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