Major 44-411

Major 44-411
SPL v2
SPL
SPL Set ID bc293912-9ae2-459d-9ac5-2bad046f7e1a
Route
ORAL
Published
Effective Date 2018-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (4 mg) Dextromethorphan (30 mg)
Inactive Ingredients
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

Identifiers & Packaging

Pill Appearance
Imprint: 411 Shape: round Color: red Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2003-05-03

Description

Chlorpheniramine maleate 4 mg Dextromethorphan HBr 30 mg 

Purpose

Antihistamine Cough suppressant 


Medication Information

Purpose

Antihistamine

Cough suppressant 

Description

Chlorpheniramine maleate 4 mg Dextromethorphan HBr 30 mg 

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 
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
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. 

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 
Active Ingredients

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg 

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, propylparaben, propylene glycol, shellac, silica gel, sodium benzoate, stearic acid, sugar, talc, titanium dioxide 

Questions Or Comments?

(800) 616-2471

Principal Display Panel

MAJOR®

NDC 63187-689-16

*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

Relabeled By: Proficient Rx LP

Thousand Oaks, CA 91320

Major 44-411
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. 

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.


Structured Label Content

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 
Purpose

Antihistamine

Cough suppressant 

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
Do Not Use (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. 

Other Information (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 
Active Ingredients (Active ingredients)

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg 

Inactive Ingredients (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, propylparaben, propylene glycol, shellac, silica gel, sodium benzoate, stearic acid, sugar, talc, titanium dioxide 

Questions Or Comments? (Questions or comments?)

(800) 616-2471

Principal Display Panel

MAJOR®

NDC 63187-689-16

*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

Relabeled By: Proficient Rx LP

Thousand Oaks, CA 91320

Major 44-411
When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use. 

Keep Out of Reach of Children. (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. 

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


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