FDA.reportPublic FDA data

Adult Tussin Cough and Chest Congestion DM

Manufacturer
Akron Pharma Inc. | SLV PHARMACEUTICALS LLC
Effective date
2022-11-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:48:12

Label at a glance#

ProductAdult Tussin Cough and Chest Congestion DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 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 mL= milliliter this adult product is not intended for use in children under 12 years of age adults and children 12 years and over: 10 mL every 4 hours children under 12 years: do not use

Storage and handling

each 5 mL contains: sodium 2 mg store between 20-25ºC(68-77ºF). Do not refrigerate

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20 mg

Guaifenesin 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

Warnings

WARNINGS SECTION

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 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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • mL= milliliter
  • this adult product is not intended for use in children under 12 years of age
  • adults and children 12 years and over: 10 mL every 4 hours
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 2 mg
  • store between 20-25ºC(68-77ºF). Do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, cherry flavor, glycerin, high fructose corn syrup, menthol crystals, purified water, sodium benzoate, sodium citrate, sodium saccharin,
sucrose.

Questions or comments?

SPL UNCLASSIFIED SECTION

1-877-225-6999

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4oz4oz

8oz8oz

16oz16oz

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-1004-4ML - Milliliter71399-1004e4f025b6-5c17-4d49-a065-c1fbca65877a12022-12-07
71399-1004-6ML - Milliliter71399-10047fb5031e-4936-45ba-9cb3-bb4c91de4e2712022-12-07
71399-1004-8ML - Milliliter71399-1004b2414437-a93d-402f-9d62-952399a750a012022-12-07

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-100471399-1004-4, 71399-1004-8, 71399-1004-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
MENTHOLL7T10EIP3AIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCROSEC151H8M554IACT

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
8b5c5f69-3ad2-44d0-ae85-599b22f4b9000ea4968d-34d6-487a-af0d-ebdc677c22d92024-01-18WarningsExact identifier
spl set id: 0ea4968d-34d6-487a-af0d-ebdc677c22d9

Reported adverse events (FAERS/openFDA)#

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