FDA.reportPublic FDA data

Childrens Cough and Chest Congestion DM

Manufacturer
CVS Pharmacy
Effective date
2021-12-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:20:39

Label at a glance#

ProductChildrens Cough and Chest Congestion DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure8 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 make coughs more productive.

Dosage and administration

do not give more than 6 doses in a 24 hour period. give the recommended number of vials below, following the instructions under How to Open and Use on the side panel. empty all liquid in each Single-Use Vial when dosing. Dosing Chart Age Dose (mL) under 6 years Consult a doctor 6-11 years 1 -2 Single-Use Vial (5mL) Every 4 hours Adults and Children over 12 years 2-4 Single-Use Vial (5mL Each) Every 4 hours

Label contents#

Full prescribing information#

Active Ingredients (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP, 5mg

Guaifenesin, USP, 100 mg

Purpose

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 make coughs more productive.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if your child is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for two 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 giving this product.

Ask a doctor before use if your child has

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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not give more than 6 doses in a 24 hour period.
  • give the recommended number of vials below, following the instructions under How to Open and Use on the side panel.
  • empty all liquid in each Single-Use Vial when dosing.
Dosing Chart
Age Dose (mL)
under 6 years Consult a doctor
6-11 years 1 -2 Single-Use Vial (5mL) Every 4 hours
Adults and Children over 12 years 2-4 Single-Use Vial (5mL Each) Every 4 hours

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerin, Mixed Berry Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Saccharine, Sorbitol, Sucralose, Trisodium Citrate Dihydrate, Xanthan Gum.

Other Information

SPL UNCLASSIFIED SECTION

  • each Single-Use Vial contains 8mg of sodium.
  • store at 20-25 °C (68-77 °F).
  • tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken.

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagePackage

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-26269842-262-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
XANTHAN GUMTTV12P4NEEIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML

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
f0869b1f-ba5b-049d-e053-2a95a90a9a3f4648f32c-d50b-45b4-bd1c-33afade803222022-12-23WarningsExact identifier
spl set id: 4648f32c-d50b-45b4-bd1c-33afade80322

Reported adverse events (FAERS/openFDA)#

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