FDA.reportPublic FDA data

SanaTos X

Manufacturer
Pharmadel LLC
Effective date
2023-11-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:02

Label at a glance#

ProductSanaTos X
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

temporarily relieves these common cold/ flu symptoms: minor aches and pains headache sore throat cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes make coughs more productive nasal congestion stuffy nose hay fever temporarily reduces fever

Dosage and administration

do not take more than directed dosing cup included do not take more than 6 doses in any 24-hour period this product is not intended for use in children under 12 years of age age dose adults & children 12 years of age & over 20 mL every 4 hours children under 12 years of age do not use

Label contents#

Full prescribing information#

Active ingredients and Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 20 mL)Purposes
Acetaminophen 650mg ......Pain reliever/fever reducer
Dextromethorphan HBr 20 mg .............Cough suppressant
Guaifenesin 400 mg .....................................Expectorant
Phenylephrine HCI 10 mg...................Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold/ flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial
  • secretions to drain bronchial tubes
  • make coughs more productive
  • nasal congestion
  • stuffy nose
  • hay fever
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning:

SPL UNCLASSIFIED SECTION

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

  • take more than 6 doses in 24 hours, which is the maximum daily amount
  • take with other drugs containing acetaminophen
  • have 3 or more alcoholic drinks every day while using this product

Allergy alert:

SPL UNCLASSIFIED SECTION

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash If an allergic reaction occurs, stop use and seek medical help right away.

Sore throat warning:

SPL UNCLASSIFIED SECTION

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician 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 or your child 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 child’s or your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • high blood pressure
  • a cough that is accompanied with excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, bronchitis, or emphysema
  • diffculty in urination due to enlargement of the prostate gland
  • heart disease
  • thyroid disease
  • diabetes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • skin rash appears
  • symptoms persist for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache.
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • nervousness, dizziness, or sleeplessness occur

These could be signs of a serious condition.

If pregnant or breastfeeding,

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 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 take more than directed
  • dosing cup included
  • do not take more than 6 doses in any 24-hour period
  • this product is not intended for use in children under 12 years of age
agedose
adults & children 12 years of age & over20 mL every 4 hours
children under 12 years of agedo not use

Other information

OTHER SAFETY INFORMATION

  • each 20 mL contains: sodium 10 mg
  • store at 59-86°F (15-30°C)
  • do not refrigerate

TAMPER EVIDENT FEATURE: Do not use if printed seal under cap is torn or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH • MÁXIMA POTENCIA

SANATOS® X

FAST ACTION/ACCIÓN RÁPIDA

ACETAMINOPHEN Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI/ACETAMINOFÉN Dextrometorfano HBr,
Guaifenesina, Fenilefrina HCl

COUGH, COLD & SORE THROAT/TOS, RESFRIADO y DOLOR DE GARGANTA

Fever/Fiebre
Aches and pains/Dolores y molestias leves
Headache/Dolor de Cabeza
Expectorant/Expectorante
Nasal decongestant/Descongestivo Nasal

For ages 12+/Para edades 12+

6 fl oz (177 mL)

Santos XSantos X

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1593450acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral SuspensionPSN2
1593450acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SuspensionSCD2
1593450acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SuspensionSY2
1593450acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SuspensionSY2
1593450APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SuspensionSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-311-06SanaTos X1 in 1 BOTTLE, WITH APPLICATORLIQUID12
55758-311-06SanaTos X1 in 1 BOXLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-311SANATOS X (ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [PHARMADEL LLC]2Current NDC, Legacy NDC, 2 package rows20231115_85b8ef3d-7318-7f3b-e053-2991aa0a0777.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-31155758-311-06

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
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
ACETAMINOPHEN362O9ITL9DACTIB
GUAIFENESIN495W7451VQACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYL GALLATE8D4SNN7V92IACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT

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
SanaTos XACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC85b8ef3d-7318-7f3b-e053-2991aa0a07772023-11-14WarningsExact identifier
ndc (package): 55758-311-06
ndc (product): 55758-311
ndc11 (package): 55758031106
spl id: 0a1d578c-3260-6795-e063-6294a90a3142
spl set id: 85b8ef3d-7318-7f3b-e053-2991aa0a0777

Reported adverse events (FAERS/openFDA)#

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