St Josephs 44-533-Delisted

Drug Labeling and Warnings

Drug Details [pdf]

HIGH BLOOD PRESSURE CHEST CONGESTION AND COUGH- dextromethorphan hbr and guaifenesin tablet, film coated 
Bedrock Brands, LLC

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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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76000-533
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	YELLOW	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	44;533
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76000-533-08	2 in 1 CARTON	12/31/2005	07/08/2019
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/31/2005	07/08/2019

Labeler - Bedrock Brands, LLC (829056162)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(76000-533)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(76000-533)

Revised: 8/2016

Document Id: 80971950-64a2-4e96-b2bf-56d415668629

Set id: db124fbc-089d-4095-a4b0-330273a12ed5

Version: 3

Effective Time: 20160825