HIGH BLOOD PRESSURE COLD AND FLU- acetaminophen and chlorpheniramine maleate tablet, 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 44-460-Delisted

Active ingredient (in each tablet)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg

Purpose

Pian reliever/fever reducer
Antihistamine 

Uses

  • temporarily relieves:
    • headaches
    • sneezing
    • runny nose
    • minor aches and pains
  • temporarily reduces fever 

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product 

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 

Ask a doctor before use if

  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland 

Ask a doctor or pharmacist before use if the user is

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin 

When using this product

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

Stop use and ask a doctor if

  • pain gets worse or lasts more than 5 days (children 6 to under 12 years) or 10 days (adults)
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

Directions

  • do not take more than directed (see overdose warning)
adults and children 12 years and over 2 tablets every 4 to 6 hours; do not take more than 12 tablets in 24 hours 
 children 6 to under 12 years of age1 tablet every 4 to 6 hours; do not take more than 5 tablets in 24 hours 
 children under 6 years of agedo not use this product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage 

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
  • protect from excessive moisture 

Inactive ingredients

corn starch, crospovidone, D&C red #28, dextrose monohydrate, FD&C blue #2, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium carboxymethylcellulosem sodium starch glycolate, stearic acid, titanium dioxide. 

Principal Display Panel

NDC 76000-460-08

ST. JOSEPH®

DECONGESTANT-FREE
HBP

COLD RELIEF for people with
High Blood Pressure
Cough &
Flu
Pain Reliever/Fever Reducer - Acetaminophen
Antihistamine - Chlorpheniramine maleate

Relieves:
• Runny Nose
• Sneezing
• Body Aches and Pains
• Fever

24 Tablets

50844    REV0512A46008

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

St. Joseph's 44-460

St. Joseph's 44-460

Questions or comments?

1-855-STJ-6381

HIGH BLOOD PRESSURE COLD AND FLU 
acetaminophen and chlorpheniramine maleate tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76000-460
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (UNII: 68401960MK)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POVIDONES (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;460
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76000-460-081 in 1 CARTON
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/31/200506/04/2018
Labeler - Bedrock Brands, LLC (829056162)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(76000-460)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(76000-460)

Revised: 6/2015
 
Bedrock Brands, LLC