FDA.reportPublic FDA data

SanaTos Multi Symptom

Manufacturer
Pharmadel LLC
Effective date
2022-05-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:00:49

Label at a glance#

ProductSanaTos Multi Symptom
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

Temporarily relieves common cold/flu symptoms: minor aches & pains headache sore throat nasal congestion due to hay fever sinus congestion helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

Dosage and administration

do not exceed recommended dosage adults and children 12 years of age and over: take 2 tablets every 6-8 hours; do not exceed 8 tablets in a 24-hour period children under 12 years of age: consult a doctor

Label contents#

Full prescribing information#

Active Ingredient & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each tablet)Purposes
Acetaminophen 325 mgPain reliever/ fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Guaifenesin 200 mg

Expectorant

Phenylephrine HCI 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves common cold/flu symptoms:

  • minor aches & pains
  • headache
  • sore throat
  • nasal congestion due to hay fever
  • sinus congestion
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver Warning:

WARNINGS SECTION

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

  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert:

WARNINGS SECTION

Acetaminophen may cause severe skine reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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

Sore throat warning:

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • with any 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, asl a doctor or pharmacist before taking this product.
  • for more than 7 days for pain and 3 days or fever, unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • throid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • a cough that is accompained by excessive phlegm (mucus)
  • a persistant or chronic cough such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin

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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed recommended dosage
  • adults and children 12 years of age and over:
  • take 2 tablets every 6-8 hours; do not exceed 8 tablets in a 24-hour period
  • children under 12 years of age: consult a doctor

Other information

OTHER SAFETY INFORMATION

  • store at room temperature 59-86F (15-30C)
  • avoid excessive heat and humidity

TAMPER EVIDENCE: Do not use if packet is open or torn.

Inactive ingredients

INACTIVE INGREDIENT SECTION

maltodextrin, microcrystalline cellulose, povidone, silicon dioxide*, sodium starch glycolate, starch, stearic acid

*may contain

Questions & comments?

OTC - QUESTIONS SECTION


+1-866-359-3478 (M-F) 9AM to 5 PM EST or www.pharmadel.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SanatosSanatos

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
55758-30255758-302-01, 55758-302-50

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
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
POVIDONEFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
STARCH, CORNO8232NY3SJIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MALTODEXTRIN7CVR7L4A2DIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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
df75f3b2-9a6f-dfb8-e053-2a95a90a04a0ad6408ff-079b-4757-e053-2995a90a53eb2022-05-20WarningsExact identifier
spl id: df75f3b2-9a6f-dfb8-e053-2a95a90a04a0
spl set id: ad6408ff-079b-4757-e053-2995a90a53eb

Reported adverse events (FAERS/openFDA)#

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