FDA.reportPublic FDA data

Dextromethorphan HBr and Guaifenesin - MEIJER DISTRIBUTION INC

Manufacturer
MEIJER DISTRIBUTION INC
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-10-07 01:02:56

Label at a glance#

ProductMeijer Children Cough and Chest Congestion DM Grape Flavor
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure13 sections

Indications and uses

▪ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold ▪ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Dosage and administration

▪ do not take more than 6 doses in any 24-hour period ▪ measure only with dosing cup provided ▪ keep dosing cup with product ▪ mL = milliliter   Age Dose children under 4 years do not use children 4 to under 6 years 5 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours adults and children 12 years and older 20 mL every 4 hours

Storage and handling

▪ each 20 mL contains: sodium 10 mg ▪ Contains low sodium ▪ store at room temperature. Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant
Expectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Do not use

OTC - DO NOT USE SECTION

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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter

 Age

Dose

children under 4 years

do not use

children 4 to under 6 years

5 mL every 4 hours

children 6 to under 12 years

10 mL every 4 hours

adults and children 12 years and older

20 mL every 4 hours

Other information

STORAGE AND HANDLING SECTION

  • each 20 mL contains: sodium 10 mg
  • Contains low sodium
  • store at room temperature. Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, glycerin, flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum.

Questions or Comments

OTC - QUESTIONS SECTION

1-866-467-2748

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE CHILDREN'S ROBITUSSIN® COUGH + CHEST CONGESTION DM ACTIVE INGREDIENTS*

NDC 79481-7470-8
Meijer  
CHILDREN'S

for ages 4 & over

COUGH+ CHESTCONGESTION DM

SUGAR FREE

DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT
GUAIFENESIN - EXPECTORANT

Relieves:

Chest Congestion/ cough & mucus

GRAPE FLAVOR

Naturally & Artificially Flavored

4 FL OZ (118 mL)

TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING

*This product is not manufactured or distributed by Pfizer, the distributor of Children’s Robitussin® Cough & Chest Congestion DM.

DIST. BY:

MEIJER DISTRIBUTION, INC

GRAND RAPIDS, MI 49544

www.meijer.com

Meijer Children's Cough & Chest Congestion DM GRAPE FLAVORMeijer Children's Cough & Chest Congestion DM GRAPE FLAVOR

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130713733974165GTIN-13: 0713733974165
EAN-13: 0713733974165
GTIN-12: 713733974165
UPC-A: 713733974165
GTIN storage (14 digits): 00713733974165		children-cough-chest-fig1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79481-747079481-7470-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-10-24full-release2026-06-01 01:40:21
22024-10-21full-release2026-06-01 00:28:03

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Children Cough and Chest Congestion DM Grape FlavorDEXTROMETHORPHAN HBR AND GUAIFENESINMEIJER DISTRIBUTION INC9121804a-e5eb-46a2-a4a7-cc625be846d12025-10-24WarningsExact identifier
ndc (package): 79481-7470-8
ndc (product): 79481-7470
ndc11 (package): 79481747008
spl set id: 9121804a-e5eb-46a2-a4a7-cc625be846d1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.