MedPath

Chest Congestion Relief DM

Dollar General 44-533

Approved
Approval ID

da053bc3-e790-4ae9-a406-2629640e97e7

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 18, 2025

Manufacturers
FDA

DOLGENCORP, LLC

DUNS: 068331990

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dextromethorphan HBr, Guaifenesin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55910-533
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Dextromethorphan HBr, Guaifenesin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2025
FDA Product Classification

INGREDIENTS (12)

DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 20 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB
GUAIFENESINActive
Quantity: 400 mg in 1 1
Code: 495W7451VQ
Classification: ACTIB
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/18/2025

Principal display panel

DG**®****| health**

Immediate
** Release**
** Tablets**

Chest
** Congestion**
** Relief DM**

Dextromethorphan HBr, 20 mg
Cough Suppressant

Guaifenesin, 400 mg
Expectorant

• Controls cough
• Thins and loosens mucus
• Immediate release

60 Tablets

Actual Tablet Size

TAMPER EVIDENT: DO NOT USE IF
** IMPRINTED SAFETY SEAL UNDER**
** CAP IS BROKEN OR MISSING**

PARENTS:
**** Learn about teen medicine abuse
www.StopMedicineAbuse.org

50844 REV1124A53311

DISTRIBUTED BY
OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072

100%
** Satisfaction**
** Guaranteed!**
(888) 309-9030

![Dollar General 44-533](/dailymed/image.cfm?name=dollar- general-44-533-1.jpg&id=894106)

Dollar General 44-533

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/18/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/18/2025

Active ingredients (in each immediate-release tablet)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/18/2025

Purpose

Cough suppressant
Expectorant

WARNINGS SECTION

LOINC: 34071-1Updated: 8/18/2025

Warnings

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.

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

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

cough persists more than 1 week, 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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/18/2025

Directions

*do not take more than directed

  • 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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/18/2025

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/18/2025

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/18/2025

Questions or comments?

1-888-309-9030

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Chest Congestion Relief DM - FDA Drug Approval Details