St Josephs 44-411SJ

Drug Labeling and Warnings

Drug Details [pdf]

COUGH AND COLD RELIEF HBP- chlorpheniramine maleate and dextromethorphan hbr tablet, sugar 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 44-411SJ

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg 

Purpose

Antihistamine
Cough suppressant 

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• temporarily relieves runny nose and sneezing due to the common cold 

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

• trouble urinating due to an enlarged prostate gland
• glaucoma
• cough that occurs with excessive phlegm (mucus)
• a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema 

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery 

Stop use and ask a doctor if

cough lasts more than 7 days, reoccurs, 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

• do not exceed recommended dose
• adults and children 12 years and over:
  • 1 tablet every 6 hours. Do not take more than 4 tablets in 24 hours.
• children under 12 years: 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

acacia, black iron oxide, calcium carbonate, carnauba wax, croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, povidone, propylene glycol, propylparaben, shellac, silica gel, sodium benzoate, stearic acid, sugar, talc, titanium dioxide 

Questions or comments?

1-855-STJ-6381

Principal Display Panel

NDC: 76000-411-08

ST. JOSEPH®

DECONGESTANT-FREE

HBP

COLD RELIEF for people with
High Blood Pressure
Cough &
Cold
Cough Suppressant - Dextromethorphan HBr
Antihistamine - Chlorpheniramine maleate

Relieves:
Cough
Runny Nose
Sneezing

Actual Size

24 Tablets

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

50844    REV0512A41108

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

St. Joseph 44-411SJ

COUGH AND COLD RELIEF HBP 
chlorpheniramine maleate and dextromethorphan hbr tablet, sugar coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76000-411
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	SJ
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76000-411-08	3 in 1 CARTON	05/03/2003	07/08/2019
1		8 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	05/03/2003	07/08/2019

Labeler - Bedrock Brands, LLC (829056162)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(76000-411)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(76000-411)

Revised: 8/2016

Document Id: 1b618184-d4d0-4cec-8e74-4cb18682168c

Set id: 5c4955b4-1740-4e89-bb25-78992ff9826d

Version: 3

Effective Time: 20160825