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High Blood Pressure Chest Congestion and Cough

Medically reviewed on August 25, 2016.

Dosage form: tablet, film coated
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 20mg, GUAIFENESIN 400mg
Labeler: Bedrock Brands, LLC
NDC Code: 76000-533

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.

St Josephs 44-533-Delisted

Active ingredients (in each immediate-release tablet)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

Purpose

Cough suppressant
Expectorant

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 

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
  • cough accompanied by too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product

do not use more than directed. 

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs 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
  • take with a full glass of water
  • adults and children 12 years of age and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: do not use 

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

Inactive ingredients

D&C yellow #10 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

1-855-STJ-6381

Principal Display Panel

NDC 76000-533-08

ST. JOSEPH®

DECONGESTANT-FREE

HBP

COLD RELIEF for people with
High Blood Pressure
CHEST
CONGESTION
& COUGH 
Cough Suppressant - Dextromethorphan HBr
Expectorant - Guaifenesin

Relieves:
• Chest Congestion
• Cough

Actual Size

24 Tablets

REV0612A53308

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

Distributed by:
St. Josephs Health Products, LLC
Baltimore, MD 21201
1-855-STJ-6381
www.stjosephaspirin.com

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

St. Joseph 44-533

HIGH BLOOD PRESSURE CHEST CONGESTION AND COUGH 
dextromethorphan hbr and guaifenesin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76000-533
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
SILICON DIOXIDE 
STEARIC ACID 
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize16mm
FlavorImprint Code44;533
Contains    
Packaging
#Item CodePackage Description
1NDC:76000-533-082 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/31/200507/08/2019
Labeler - Bedrock Brands, LLC (829056162)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(76000-533)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(76000-533)

 
Bedrock Brands, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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