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Cough and Cold by Major Pharmaceuticals

Medically reviewed on March 4, 2017

Dosage form: tablet, sugar coated
Ingredients: CHLORPHENIRAMINE MALEATE 4mg, DEXTROMETHORPHAN HYDROBROMIDE 30mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-5817

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.

Major 44-411

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

persistent cough lasts for more than one week, tends to recur, or is accompanied by 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 (1-800-222-1222) 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
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • 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 stearate, methylparaben, microcrystalline cellulose, povidone, propylene glycol, propylparaben, shellac, silica gel, sodium benzoate, stearic acid, sugar, talc, titanium dioxide

Questions or comments?

(800) 616-2471

Principal Display Panel

MAJOR®

NDC 0904-5817-44

*Compare to the
active ingredients in
Coricidin® HBP Cough & Cold

Cough &
Cold

Relief for people with
High Blood
Pressure

Chlorpheniramine maleate - Antihistamine
Dextromethorphan HBr - Cough Suppressant

Decongestant Free

Relieves
• Cough • Runny Nose • Sneezing

16 TABLETS

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

*This product is not manufactured or distributed by MSD Consumer Care,
Inc., owner of the registered trademark Coricidin® HBP Cough & Cold.
50844        REV0714D41121

Distributed by MAJOR® PHARMACEUTICALS
31778 Enterprise Drive, Livonia, MI 48150 USA    M-17
Re-order No. 873602                                Rev. 08/14

Major 44-411

COUGH AND COLD 
chlorpheniramine maleate, dextromethorphan hbr tablet, sugar coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5817
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 
MAGNESIUM STEARATE 
METHYLPARABEN 
MICROCRYSTALLINE CELLULOSE 
POVIDONE, UNSPECIFIED 
PROPYLPARABEN 
PROPYLENE GLYCOL 
SHELLAC 
SODIUM BENZOATE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
FERROSOFERRIC OXIDE 
FD&C YELLOW NO. 6 
LACTOSE, UNSPECIFIED FORM 
SILICON DIOXIDE 
SUCROSE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize9mm
FlavorImprint Code411
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5817-442 BLISTER PACK in 1 CARTON
18 TABLET, SUGAR COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/03/2003
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0904-5817)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0904-5817)

 
Major Pharmaceuticals

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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