Your browser does not support JavaScript! COUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.]
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COUGH AND COLD RELIEF HBP (chlorpheniramine maleate and dextromethorphan hbr) tablet
[SUPERVALU INC.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 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 presistent 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 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 was, croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose, magnesium searate, methylparaben, microcrystalline cellulose, povidone, propylparaben, propylene glycol, shellac, silica gel, sodium benzoate, stearic acid, sugar, talc, titanium dioxide 

Principal Display Panel

equaline®

compare to the active ingredients Coricidin® HBP Cough & Cold*

NDC 41163-411-21

cough &
cold relief
hbp
antihistamine/chlropheniramine maleate
cough suppressant/dextromethorphan HBr

decongestant-free relief for people
with high blood pressure
relieves:
• cough
• runny nose
• sneezing

16 tablets

*This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Coricidin® HBP Cough & Cold.
50844    REV0512B41121

DISTRIBUTED BY SUPERVALU INC.
EDEN PRARIE, MN 55344 USA

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

Equaline 44-411

Equaline 44-411

COUGH AND COLD RELIEF HBP 
chlorpheniramine maleate and dextromethorphan hbr tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41163-411
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
CALCIUM CARBONATE 
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
LACTOSE 
MAGNESIUM STEARATE 
METHYLPARABEN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONES 
PROPYLPARABEN 
PROPYLENE GLYCOL 
SHELLAC 
SODIUM BENZOATE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;411
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-411-211 in 1 CARTON
116 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/03/2003
Labeler - SUPERVALU INC. (006961411)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(41163-411)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(41163-411)

Revised: 5/2013
 
SUPERVALU INC.

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