Safetussin

Manufacturer
Denison Pharmaceuticals, LLC.
Effective date
2022-11-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:49:47

Label at a glance#

ProductSafetussin DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure11 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation loosens phlegm (mucus) helps rid bronchial passages of phlegm (mucus)

Dosage and administration

do not take more than 6 doses in any 24-hour period this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2 teaspoons every 4 hours children under 12 years do not use

Storage and handling

Protect from excessive heat and freezing. Store at 15° - 30° C (59° - 86° F) Phenylketonurics: each teaspoon contains phenylalanine 4.2 mg Save this package for complete information

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

SPL UNCLASSIFIED SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 5ml tsp)Purpose
Dextromethorphan HBr,USP 10 mgCough Suppressant
Guaifenesin, USP 100 mg Expectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation
  • loosens phlegm (mucus)
  • helps rid bronchial passages of phlegm (mucus)

Warnings

WARNINGS SECTION

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

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

OTC - STOP USE SECTION

Stop use and ask a doctor if 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.

NURSING MOTHERS SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
agedose
adults and children
12 years and over
2 teaspoons
every 4 hours
children under 12 yearsdo not use

Other information:

STORAGE AND HANDLING SECTION

  • Protect from excessive heat and freezing. Store at 15° - 30° C (59° - 86° F)
  • Phenylketonurics: each teaspoon contains phenylalanine 4.2 mg

Save this package for complete information

INACTIVE INGREDIENT SECTION

Inactive ingredients: aspartame, benzoic acid, citric acid, glycerin, menthol, methylparaben, natural peppermint flavor, propylene glycol, propylparaben, purified water

SAFETUSSIN DM (DEXTROMETHORPAN GUAIFENESIN) LIQUID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-11110295-1111-17, 0295-1111-28

Ingredients#

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

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

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
ec942206-ebdb-6918-e053-2995a90a84998e32e6cf-00e6-4e39-83a1-0d824fd44f742022-11-03WarningsExact identifier
spl id: ec942206-ebdb-6918-e053-2995a90a8499
spl set id: 8e32e6cf-00e6-4e39-83a1-0d824fd44f74

Reported adverse events (FAERS/openFDA)#

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