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

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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

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

30 Tablets

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

Relabeled by Proficient Rx LP
Thousand Oaks, CA 91320


Rev. 12/14    M-17      Re-order No. 006474

63187-587-30

MUCUS RELIEF SINUS 
guaifenesin and phenylephrine hcl tablet, film coated
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (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 CARTON12/01/2015
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:63187-587-601 in 1 CARTON12/01/2015
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 DrugM01204/15/2006
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(63187-587) , RELABEL(63187-587)

Revised: 10/2023
Document Id: a4a873d0-68ca-476c-9286-b8b99c81da9c
Set id: 2b79565f-5038-4cc4-ad75-2c6692411405
Version: 3
Effective Time: 20231001
 
Proficient Rx LP