Major 44-542

Major 44-542

Drug Labeling and Warnings

Drug Details

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MUCUS RELIEF SINUS- guaifenesin and phenylephrine hcl tablet 
Proficient Rx LP

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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Major 44-542

Active ingredients (in each immediate-release tablet)

Guaifenesin 400 mg
Phenylephrine HCl 10 mg

Purpose

Expectorant
Nasal decongestant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • promotes nasal and/or sinus drainage
  • temporarily relieves sinus congestion and pressure

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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • cough comes back or worsens
  • symptoms do not improve within 7 days, come back or occur with fever, rash or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years of age and older: take 1 tablet every 4 hours, with a full glass of water, while symptoms persist. Do not exceed 6 tablets in 24 hours.
  • children under 12 years of age: do not use

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Principal Display Panel

MAJOR®

NDC: 63187-587-30

Mucus Relief
Sinus

Guaifenesin 400 mg /
Phenylephrine HCl 10 mg

Expectorant / Nasal Decongestant

  • Alleviates Chest Congestion
  • Relieves Nasal/Sinus Congestion
  • Does Not Contain Pseudoephedrine

30Tablets

Immediate
Release

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844        REV0612D54201
Distributed by Major Pharmaceuticals
31778 Enterprise Drive, Livonia, MI 48150 USA
Rev. 12/14    M-17      Re-order No. 006474

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

63187-587-30

Major 44-542

MUCUS RELIEF SINUS 
guaifenesin and phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63187-587(NDC: 0904-5792)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize16mm
FlavorImprint Code 44;542
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63187-587-301 in 1 CARTON
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC: 63187-587-601 in 1 CARTON
260 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/15/2006
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079502574REPACK(63187-587) , RELABEL(63187-587)

Revised: 11/2015
 
Proficient Rx LP


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