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

Purpose

Antihistamine Cough suppressant 

Description

Chlorpheniramine maleate 4 mg Dextromethorphan HBr 30 mg 


Medication Information

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

Description

Chlorpheniramine maleate 4 mg Dextromethorphan HBr 30 mg 

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
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. 

Active Ingredients

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg 

Questions Or Comments?

(800) 616-2471

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
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 
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 

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
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. 

Active Ingredients (Active ingredients)

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg 

Questions Or Comments? (Questions or comments?)

(800) 616-2471

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.


Advanced Ingredient Data


Raw Label Data

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