SAFETUSSIN Non Drowsy

Manufacturer
KRAMER LABORATORIES | RARITAN PHARMACEUTICALS INCORPORATED
Effective date
2025-12-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:29:32

Label at a glance#

ProductSAFETUSSIN Non Drowsy Cough plus chest congestion
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections

Indications and uses

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

Dosage and administration

adults and children 12 years and over : take 1-2 caplets every 4 hours as needed. Children under 12 years: do not use Do not take more than 12 caplets in any 24-hour period.

Storage and handling

Store at 15° - 30°C (59° - 86°F) Keep this carton for future reference on full labeling

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in one caplet)Purpose

Dextromethorphan HBr 10 mg

Cough suppressant

Guaifenesin 200 mg

Expectorant

Uses

INDICATIONS & USAGE SECTION

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

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.

OTC - PREGNANCY OR BREAST FEEDING 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

  • adults and children 12 years and over: take 1-2 caplets every 4 hours as needed.
  • Children under 12 years:do not use

    Do not take more than 12 caplets in any 24-hour period.

Other information

STORAGE AND HANDLING SECTION

  • Store at 15° - 30°C (59° - 86°F)
  • Keep this carton for future reference on full labeling

Inactive ingredients

INACTIVE INGREDIENT SECTION

Crospovidone, flavor, Hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, stearic acid, sucralose,

Questions or Comments?

OTC - QUESTIONS SECTION

1-866-467-2748

SPL UNCLASSIFIED SECTION

Distributed by

©2024 Kramer Laboratories, Inc Bridgewater, NJ 08807

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES

NDC 55505-231-24

Safetussin® DM

NON-DROWSY

Cough+Chest

Congestion

Dextromethorphan HBr / Cough Suppressant

Guaifenesin / Expectorant

Safe for adults with

High Blood Pressure

Diabetes

  • Control cough
  • Loosens mucus
  • Relives chest congestion

SUGAR & DECONGESTANT FREE

24 Caplets

  • No decongestants
  • No acetaminophen
  • No Sugar
  • No Alcohol
  • No sorbitol
  • No fructose
  • No gluten
  • No dyes
SAFETUSSIN NON-DROWSY COUGH+CHEST CONGESTION 24 CAPLETS
SAFETUSSIN NON-DROWSY COUGH+CHEST CONGESTION 24 CAPLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2173726dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral TabletPSN3
2173726dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral TabletSCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130053076000092GTIN-13: 0053076000092
EAN-13: 0053076000092
GTIN-12: 053076000092
UPC-A: 053076000092
GTIN storage (14 digits): 00053076000092
NQ HBP 8OZ.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55505-231-24SAFETUSSIN Non DrowsyCough plus chest congestion24 in 1 CARTONTABLET243

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55505-23155505-231-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
SAFETUSSIN Non Drowsy Cough plus chest congestionDEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIESeeca6370-29ea-4540-8139-e8461d58a2862025-12-23WarningsExact identifier
ndc (package): 55505-231-24
ndc (product): 55505-231
ndc11 (package): 55505023124
spl id: 4c618596-e3fe-4557-8ccb-0867ebb871c9
spl set id: eeca6370-29ea-4540-8139-e8461d58a286

Reported adverse events (FAERS/openFDA)#

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