Premier Value 44-533 Delisted

Premier Value 44-533 Delisted
SPL v5
SPL
SPL Set ID 9e32e9a9-b378-4f1d-82c4-c1769954fc10
Route
ORAL
Published
Effective Date 2025-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
D&c Yellow No. 10 Aluminum Lake Hypromellose, Unspecified Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 44;533 Shape: oval Color: yellow Size: 16 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-01-12 Until 2026-03-31

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Purpose

Cough suppressant Expectorant 


Medication Information

Purpose

Cough suppressant

Expectorant 

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

  • temporarily relieves:

    • cough due to minor throat and bronchial irritation associated with the common cold
    • the intensity of coughing
    • the impulse to cough to help you get to sleep

Directions
  • take with a full glass of water
  • adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 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
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 
Inactive Ingredients

D&C yellow #10 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions Or Comments?

1-800-426-9391

Principal Display Panel

Premier

Value®

Immediate release

Mucus Relief DM

DEXTROMETHORPHAN HBr, 20 mg

GUAIFENESIN, 400 mg

Cough Suppressant

Expectorant

Controls Cough

Thins and Loosens Mucus

actual size

50 Tablets

50844 ORG011853315

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

If for any reason you are not satisfied with

this product, please return it to the store

where purchased for a full refund.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Premier Value 44-533

When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If

cough persists more than 7 days, tends to recur, or is accompanied by a 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.

Ask A Doctor Before Use If You Have
  • cough accompanied by too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Active Ingredients (in Each Immediate Release Tablet)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg


Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

  • temporarily relieves:

    • cough due to minor throat and bronchial irritation associated with the common cold
    • the intensity of coughing
    • the impulse to cough to help you get to sleep

Purpose

Cough suppressant

Expectorant 

Directions
  • take with a full glass of water
  • adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 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)
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 
Inactive Ingredients (Inactive ingredients)

D&C yellow #10 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

Premier

Value®

Immediate release

Mucus Relief DM

DEXTROMETHORPHAN HBr, 20 mg

GUAIFENESIN, 400 mg

Cough Suppressant

Expectorant

Controls Cough

Thins and Loosens Mucus

actual size

50 Tablets

50844 ORG011853315

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

If for any reason you are not satisfied with

this product, please return it to the store

where purchased for a full refund.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Premier Value 44-533

When Using This Product (When using this product)

do not exceed recommended dosage.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough persists more than 7 days, tends to recur, or is accompanied by a 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • cough accompanied by too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Active Ingredients (in Each Immediate Release Tablet) (Active ingredients (in each immediate-release tablet))

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg


Advanced Ingredient Data


Raw Label Data

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