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

St. Joseph 44-411SJ

COUGH AND COLD RELIEF HBP 
chlorpheniramine maleate and dextromethorphan hbr tablet, sugar coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76000-411
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScoreno score
ShapeROUNDSize9mm
FlavorImprint Code SJ
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76000-411-083 in 1 CARTON05/03/200307/08/2019
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/03/200307/08/2019
Labeler - Bedrock Brands, LLC (829056162)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(76000-411)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(76000-411)

Revised: 8/2016
Document Id: 1b618184-d4d0-4cec-8e74-4cb18682168c
Set id: 5c4955b4-1740-4e89-bb25-78992ff9826d
Version: 3
Effective Time: 20160825
 
Bedrock Brands, LLC