FDA.reportPublic FDA data

SAFETUSSIN MAX STRENGTH MS

Manufacturer
KRAMER LABORATORIES | RARITAN PHARMACEUTICALS INCORPORATED
Effective date
2025-12-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:29:21

Label at a glance#

ProductSAFETUSSIN MAX STRENGTH MS Cough, Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections

Indications and uses

temporarily relieves common cold and flu symptoms: cough sore throat headache minor aches and pains fever helps loosen phlegm (mucus) and thin bronchial secretions to get rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and administration

do not use more than directed. adults & children 12 years & over Take 2 caplets every 4 hours (do not take more than 12 caplets in 24 hours) children under 12 years of age do not use

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 each caplet)Purpose

Acetaminophen 325 mg

Pain reliever/fever reducer

Dextromethorphan HBr 10 mg

Cough suppressant

Guaifenesin 200 mg

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves common cold and flu symptoms:
  • cough
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to get rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4000mg of acetaminophen in 24 hours, which is the maximum daily amount for this product in 24 hours
  • taken with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

SPL UNCLASSIFIED SECTION

Allergy Alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:

  • Skin reddening
  • Blisters
  • Rash

If a skin reaction occurs, stop use and seek medical help right away

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.
  • If you have ever had an allergic reaction to this product r any of its ingredients
  • In children under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • Do not use more than as directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts.

    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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed.

adults & children 12 years & over

Take 2 caplets every 4 hours (do not take more than 12 caplets in 24 hours)

children under 12 years of age

do not use

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

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES

NDC 55505-230-24

Safetussin®

MAX STRENGTH

MULTI-SYMPTOM

Cough, Cold & Flu

Acetaminophen / Pain Reliever

Dextromethorphan HBr / Cough Suppressant

Guaifenesin / Expectorant

Safe for adults with

High Blood Pressure

Diabetes

Relieves

  • Headache
  • Fever
  • Sore Throat
  • Body Aches & Pains
  • Chest Congestion
  • Cough

Safetussin® contains:

No decongestants

No Sugar

No Alcohol

No sorbitol

No fructose

No gluten

No dyes

SUGAR & DECONGESTANT FREE

24 Caplets

Always read and follow label directions. Do not use longer than 7 consecutive days unless directed by a doctor. Ask a doctor if you have individual health questions.

©2024 Kramer Laboratories, Inc. Bridgewater, NJ 08807

SAFETUSSIN MS Cough Cold Flu 24 Caplets
SAFETUSSIN MS Cough Cold Flu 24 Caplets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2684921acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral TabletPSN2
2684921acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral TabletSCD2
2684921acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG Oral TabletSY2
2684921APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral TabletSY2

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-130053076000085GTIN-13: 0053076000085
EAN-13: 0053076000085
GTIN-12: 053076000085
UPC-A: 053076000085
GTIN storage (14 digits): 00053076000085		NQ HBP 8OZ.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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55505-230-24SAFETUSSIN MAX STRENGTH MSCough, Cold and Flu24 in 1 CARTONTABLET242

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
55505-23055505-230-24

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
CROSPOVIDONE (120 .MU.M)68401960MKIACT
HYPROMELLOSE 2208 (100 MPA.S)B1QE5P712KIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT
ACETAMINOPHEN362O9ITL9DACTIB
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
SAFETUSSIN MAX STRENGTH MS Cough, Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES920bde5f-4079-45de-aa59-24b00e50cb562025-12-23WarningsExact identifier
ndc (package): 55505-230-24
ndc (product): 55505-230
ndc11 (package): 55505023024
spl id: 3dbd264d-5108-4b29-8881-728cea879dd7
spl set id: 920bde5f-4079-45de-aa59-24b00e50cb56

Reported adverse events (FAERS/openFDA)#

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