Sanatos Multi Symptom Daytime

Manufacturer
Pharmadel LLC
Effective date
2019-12-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:54:29

Label at a glance#

ProductSanatos Multi Symptom Daytime
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN
Label structure9 sections

Indications and uses

temporarily relieves common cold/flu symptoms: minor aches & pains headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation

Dosage and administration

take only as recommended (see overdose warning) use dosage cup or tablespoon (TBSP) do not exceed 4 doses per 24 hrs age dose adults & children 12 years & over 30 mL (2 TBSP) every 6 hours children 6 years to under 12 years 15 mL (1 TTBSP) every 4 hours children 4 years to under 6 years ask a doctor children under 4 years do not use when using daytime and nighttime products, carefully read each label to ensure cor...

Label contents#

Full prescribing information#

Active Ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients

(in each 15 mL, 1 tablespoon)

Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCI 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • minor aches & pains
  • headache
  • sore throat
  • fever
  • nasal congestion
  • cough due to minor throat and bronchial irritation

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • adults take more than 4,000 mg if acetaminophen in 24 hours
  • child take more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

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: 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

  • 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.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed (see overdose warning)
  • avoid alcoholic drinks

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervos, dizzy or sleepless
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts

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 this and all drugs out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning:

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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

  • take only as recommended (see overdose warning)
  • use dosage cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hrs
agedose
adults & children 12 years & over30 mL (2 TBSP) every 6 hours
children 6 years to under 12 years 15 mL (1 TTBSP) every 4 hours
children 4 years to under 6 years ask a doctor
children under 4 yearsdo not use
  • when using daytime and nighttime products, carefully read each label to ensure correct dosing.

Other information

OTHER SAFETY INFORMATION

  • sodium content per tablespoon: 10 mg
  • store at room temperature

TAMPER EVIDENT: Do not use if imprinted band is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purfied water, saccarhin sodium, sodium benzoate, sucrose

Questions?

OTC - QUESTIONS SECTION

call 1-866-359-3478

Distributed by:

SPL UNCLASSIFIED SECTION

Pharmadel LLC

Seaford, DE 19973

www.sanatos.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alcholo-Free / Antihistamine Free

NDC 55758-022-06

Sanatos® Daytime

Multi-Symprom Cold & Flu Relief

Acetaminophen,

Dextromethrophan HBr, Phenylephrine HCI

  • Minor Aches & Pains, Fever
  • Sore Throat
  • Nasal Decongestion
  • Cough

New & Improved

Non-Drowsy

6 FL OZ (177mL)

Sanatos Multi-Symptoms DaySanatos Multi-Symptoms Day

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-02255758-022-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
0ab262c2-49cf-22da-e063-6394a90a465060506714-179c-6714-e053-2991aa0a51b32023-11-21WarningsExact identifier
spl set id: 60506714-179c-6714-e053-2991aa0a51b3

Reported adverse events (FAERS/openFDA)#

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