Cough and Cold description, usages, side effects, indications, overdosage, supplying and lots more!

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Cough and Cold

Major Pharmaceuticals

Major 44-411


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg 

Antihistamine

Cough suppressant 

  • 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 

Do not use

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. 

  • 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
  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

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 

 1-800-426-9391

Principal Display Panel

MAJOR®

NDC 0904-5817-44

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

Cough & Cold

Antihistamine - Chlorpheniramine maleate

Cough Suppressant - Dextromethorphan HBr

Decongestant Free

Cough & Cold Relief for people with High Blood Pressure

Relieves

• Cough • Runny Nose • Sneezing

16 TABLETS

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

50844    REV0710B41121

Distributed by MAJOR PHARMACEUTICALS

31778 Enterprise Drive, Livonia, MI 48150 USA    M-17

Re-order No. 873602    Rev. 11/10

Cough and Cold

Cough and Cold

Chlorpheniramine maleate TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-5817
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 4 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 30 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
RED 11 mm 411 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 16 in 1 BLISTER PACK
2 NDC:0904-5817-44 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2003-05-03


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Be sure to consult your doctor before taking any medication!
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