Quality Choice 44-689 Delisted

Quality Choice 44-689 Delisted
SPL v11
SPL
SPL Set ID 320152b8-17ef-40c0-8e4b-cd8f846ae6f5
Route
ORAL
Published
Effective Date 2024-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (4 mg) Dextromethorphan (30 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Red No. 27 Aluminum Lake Fd&c Yellow No. 6 Anhydrous Lactose Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;689 Shape: round Color: red Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2017-03-31 Until 2026-07-24

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

Warnings


Directions
  • do not exceed recommended dose
  • adults and children 12 years and over: 1 tablet every 6 hours, not 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

Inactive Ingredients

croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide



Questions Or Comments?

1-800-426-9391

Principal Display Panel

QC®

QUALITY

CHOICE

NDC 63868-179-16

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

Cough &

Cold HBP

Chlorpheniramine Maleate | Antihistamine

Dextromethorphan HBr | Cough Suppressant

For People with High Blood Pressure

Decongestant-Free

Temporarily Relieves:

Cough

Runny Nose

Sneezing

24 Tablets

Actual Size

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 Bayer HealthCare LLC, owner of the registered trademark Coricidin® HBP Cough & Cold.

50844  REV0121A68908

Distributed by C.D.M.A., Inc.©

43157 W. 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Quality Choice 44-689


When Using This Product
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • 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 right away.

Active Ingredients (in Each Tablet)

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg

Ask A Doctor Before Use If You Have
  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with excessive phlegm (mucus)
  • glaucoma
  • 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

Warnings


Directions
  • do not exceed recommended dose
  • adults and children 12 years and over: 1 tablet every 6 hours, not 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

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide



Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

QC®

QUALITY

CHOICE

NDC 63868-179-16

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

Cough &

Cold HBP

Chlorpheniramine Maleate | Antihistamine

Dextromethorphan HBr | Cough Suppressant

For People with High Blood Pressure

Decongestant-Free

Temporarily Relieves:

Cough

Runny Nose

Sneezing

24 Tablets

Actual Size

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 Bayer HealthCare LLC, owner of the registered trademark Coricidin® HBP Cough & Cold.

50844  REV0121A68908

Distributed by C.D.M.A., Inc.©

43157 W. 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Quality Choice 44-689


When Using This Product (When using this product)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • 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 right away.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with excessive phlegm (mucus)
  • glaucoma
  • 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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