Palatos Expectorante

Manufacturer
All Pharma, LLC
Effective date
2021-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:49:35

Label at a glance#

ProductPalatos Expectorante
Active ingredientGUAIFENESIN
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Acvtive ingredients: (in each 5ml)              Purpose

Guaifenesin 100 mg ................................... Expectorant

OTC - PURPOSE SECTION

Purpose

Expectorant

INDICATIONS & USAGE SECTION

Uses

  • Help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.

WARNINGS SECTION

Warnings

Do not exceed recommended dosage

OTC - DO NOT USE SECTION

Do not use

  • if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor

Ask the doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

OTC - STOP USE SECTION

Stop use and ask the doctor if

  • Nervoisness, dizziness or sleeplessness occurs.
  • Cough persists for more than 1 week, tends to recur, or accompanied by fever, rash or persistent headache. A persistent cough may be sign of a serious condition

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Do not take more than 6 doses in any 24-hour period
  • Shake well before use

Age                                                                        Dose

Adults and children 12 years and over           10 mL (2 tsps) every 4 hours

Children 6 to under 12 years of age.               5 mL (1 tsps) every 4 hours

Children under 6 years of age                       Do not use

INACTIVE INGREDIENT SECTION

Inactive ingredients

Blue cohosh, citric acid, echinacea, eucalyptus oil, ginkgo biloba, glycerin, gold seal root, honey flavor, horehound herb, licorice root, menthol, mullein, myrrh, potassium sorbate, slippery elm bark, sodium benzoate, propylene glycol, water, sodium chloride, sucralose, wild cherry bark and zinc sulfate.

Palatos

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN3
310604guaifenesin 20 MG/ML Oral SolutionSCD3
310604guaifenesin 100 MG per 5 ML Oral SolutionSY3
310604guaifenesin 100 MG per 5 ML Oral SyrupSY3
310604guaifenesin 200 MG per 10 ML Oral SolutionSY3
310604guaifenesin 300 MG per 15 ML Oral SolutionSY3
310604guaifenesin 400 MG per 20 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53149-2000-6Palatos Expectorante1 in 1 BOXLIQUID13
53149-2000-6Palatos Expectorante177 mL in 1 BOTTLELIQUID1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53149-2000PALATOS EXPECTORANTE (GUAIFENESIN) LIQUID [ALL PHARMA, LLC]3Legacy NDC, 2 package rows20220517_d7786e19-8809-469c-8e84-761f231268e1.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53149-200053149-2000-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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
9c51c482-adea-4b02-b5fd-ac52ddbdd22cd7786e19-8809-469c-8e84-761f231268e12021-12-31WarningsExact identifier
spl id: 9c51c482-adea-4b02-b5fd-ac52ddbdd22c
spl set id: d7786e19-8809-469c-8e84-761f231268e1

Reported adverse events (FAERS/openFDA)#

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