MAXIFED- guaifenesin and pseudoephedrine 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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Maxifed

Drug Facts

Active Ingredients (in each immediate-release tablet)Purpose
Guaifenesin 360 mgExpectorant
Pseudoephedrine HCl 60 mgNasal Decongestant

Uses

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

Warnings

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

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 4 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 2 tablets in 24 hours, or as directed by a doctor.
Children 2 to under 6 years of ageconsult a doctor

Inactive ingredients

Magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

Call 1-352-754-8587

PRINCIPAL DISPLAY PANEL - 360 mg/60 mg Tablet Bottle Label

NDC 58605-101-01
100 tablets

Maxifed

Expectorant • Nasal Decongestant

Each immediate-release tablet contains:
Guaifenesin 360 mg
Pseudoephedrine HCl 60 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 - 360 mg/60 mg Tablet Bottle Label
MAXIFED 
guaifenesin and pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58605-101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN360 mg
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride60 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 MAXIFED
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58605-101-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2018
2NDC:58605-101-2020 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(58605-101)

Revised: 3/2018
Document Id: f954e296-1429-4985-9d04-a20b67e2cf71
Set id: 8a1be614-2a78-4899-9697-774479f2daa5
Version: 1
Effective Time: 20180315
 
MCR American Pharmaceuticals, Inc.