FDA.reportPublic FDA data

Sanatos

Manufacturer
Pharmadel LLC
Effective date
2019-09-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:08:20

Label at a glance#

ProductSanatos
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN
Label structure7 sections

Dosage and administration

Daytime & Nighttime take only as directed do not exceed 4 doses in a 24-hour period even if taking both Daytime and Nighttime, total limit per day is 4 doses per 24 hour period adults & children 12 years & over: take two (2) liquicaps with water every 4 hours children 4 to under 12 years consult a doctor children under 4 years: do not use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Daytime Relief

Active ingredients (in each liquicap)

Purposes
Acetaminophen 325 mg.......Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg..............Cough suppressant
Phenylephrine HCI 5 mg.......................Nasal decongestant

Nighttime Relief

Active ingredients (in each liquicap)Purposes
Acetaminophen 325 mg........Pain reliever/ fever reducer
Dextromethorphan HBr 15 mg...............Cough suppressant
Doxylamine succinate 6.25 mg........................Antihistamine

Use

INDICATIONS & USAGE SECTION

Daytime Relief

Temporarily relieves common cold/flu symptoms:

  • headache
  • minor aches and pains
  • sore throat
  • nasal and sinus congestion
  • stuffy nose Temporarily reduces fever

Nighttime Relief

Temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • headache
  • minor aches and pains
  • sneezing
  • sore throat
  • runny nose
  • itchy nose or throat
  • itchy, watery eyes due to hay fever
  • Temporarily reduces fever

Warnings

WARNINGS SECTION

Liver Warning:

OTHER SAFETY INFORMATION

Daytime & Nighttime

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

  • more than 4 doses 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: Acetaminophen

OTHER SAFETY INFORMATION

Daytime & Nighttime

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:

OTHER SAFETY INFORMATION

Daytime & Nighttime

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

Daytime & Nighttime

  • 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.

  • for more than 3 days for fever, unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Daytime

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

Nighttime

  • liver disease
  • glaucoma
  • a cough that is accompanied by excessive phlegm (mucus)
  • a breathing problem, persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

Daytime

  • taking the blood thinning drug warfarin

Nighttime

  • taking sedatives or tranquilizers
  • taking bloodthinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

Daytime

  • symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache.
  • new symptoms occur
  • redness or swelling is present
  • nervousness, dizziness, or sleeplessness occur.These could be signs of a serious condition.

Nighttime

  • pain or cough gets worse or lasts more than 5 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, occurs with rash or a persistent headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

Daytime & Nighttime

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Daytime & Nighttime

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

Daytime & Nighttime

take only as directed

  • do not exceed 4 doses in a 24-hour period
  • even if taking both Daytime and Nighttime, total limit per day is 4 doses per 24 hour period
  • adults & children 12 years & over: take two (2) liquicaps with water every 4 hours
  • children 4 to under 12 years consult a doctor
  • children under 4 years: do not use

Other information

OTHER SAFETY INFORMATION

Daytime & Nighttime

store at room temperature 68-77°F (20-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Daytime

FD&C yellow #6, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol,

Nighttime

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, sorbitan, titanium dioxide.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sanatos ®

MULTI SYMPTOM / MULTI SÍNTOMAS

Daytime Relief / Alivio Durante el Día

Acetaminophen, Dextromethorphan HBr,
Phenylephrine HCI/Acetaminofén, Dextrometorfano HBr, Fenilefrina HCI

  • Sore Throat / Dolor de Garganta
  • Nasal Congestion / Congestión Nasal
  • Aches & Fever / Dolores y Fiebre
  • Headache / Dolor de Cabeza
  • Cough / Tos

Non-Drowsy
No causa sueño

Daytime Liquicaps
12 Liquicaps de Dia

Sanatos ®

Nighttime Relief/Alivio Durante la Noche

Acetaminophen, Dextromethorphan HBr,
Doxylamine Succinate
Acetaminofén, Dextrometorfano HBr,
Sucinato de Doxilamina

  • Sore Throat / Dolor de Garganta
  • Aches & Fever / Dolor y Fiebre
  • Runny Nose / Secreción Nasal
  • Sneezing / Estornudos
  • Cough / Tos

Nighttime Liquicaps
12 Liquicaps de Noche

Sanatos 2 in 1Sanatos 2 in 1

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-14155758-141-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C RED NO. 40WZB9127XOAIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ACETAMINOPHEN362O9ITL9DACTIB

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
937a8bab-9212-089f-e053-2a95a90abf22937a8bab-9211-089f-e053-2a95a90abf222019-09-26WarningsExact identifier
spl id: 937a8bab-9212-089f-e053-2a95a90abf22
spl set id: 937a8bab-9211-089f-e053-2a95a90abf22

Reported adverse events (FAERS/openFDA)#

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