FDA.reportPublic FDA data

SanaTos Mucus Relief Cold Toddlers

Manufacturer
Pharmadel LLC
Effective date
2025-02-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:54:43

Label at a glance#

ProductSanaTos Mucus Relief Cold Toddlers
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure8 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes

Dosage and administration

do not give a child more than 6 doses in 24 hour period repeat the dose every 4 hours use only included oral syringe to measure dose Age Dose children 2 to under 6 years of age 2.5 mL every 4 hours children under 2 years of age consult a doctor

Label contents#

Full prescribing information#

Active Ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 2.5 mL)Purposes
Dextromethorphan HBr 2.5 mg .....

Cough suppressant

Guaifenesin 50 mg............Expectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

in a child who is 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 prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has a

OTC - ASK DOCTOR SECTION

  • cough that is accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

When using this product

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor, if the child has a

OTC - STOP USE SECTION

cough that persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not give a child more than 6 doses in 24 hour period
  • repeat the dose every 4 hours
  • use only included oral syringe to measure dose
AgeDose
children 2 to under 6 years of age2.5 mL every 4 hours
children under 2 years of ageconsult a doctor

Other information

OTHER SAFETY INFORMATION

■ store between 68-77°F (20-25°C)

■ do not refrigerate

■ keep carton for full direction for use

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, propylene glycol, sodium benzoate, sorbitol solution, sucralose, xanthan gum, water

Questions?

OTC - QUESTIONS SECTION

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

Distributed by / Distribuido por:

PHARMADEL LLC

New Castle, DE 19720

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sanatos toddlers PDPSanatos toddlers PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN6
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD6
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY6
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

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

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
55758-307-02SanaTos Mucus Relief Cold Toddlers59 mL in 1 BOTTLE, WITH APPLICATORLIQUID596

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-307SANATOS MUCUS RELIEF COLD TODDLERS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [PHARMADEL LLC]6Current NDC, Legacy NDC, 1 package rows20250210_60672feb-1421-651e-e053-2a91aa0af41d.zip

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
55758-30755758-307-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL SOLUTION8KW3E207O2IACT
SODIUM BENZOATEOJ245FE5EUIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
XANTHAN GUMTTV12P4NEEIACT
SUCRALOSE96K6UQ3ZD4IACT
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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 Mucus Relief Cold ToddlersDEXTROMETHORPHAN HBR, GUAIFENESINPharmadel LLC60672feb-1421-651e-e053-2a91aa0af41d2025-02-04WarningsExact identifier
ndc (package): 55758-307-02
ndc (product): 55758-307
ndc11 (package): 55758030702
spl id: 2d58d9b1-2c02-42e2-e063-6294a90a205c
spl set id: 60672feb-1421-651e-e053-2a91aa0af41d

Reported adverse events (FAERS/openFDA)#

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