GUNA-COUGH

Manufacturer
Guna spa
Effective date
2020-10-23
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:13:26

Label at a glance#

ProductGUNA-COUGH
Active ingredientALTHAEA OFFICINALIS LEAF, ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, CETRARIA ISLANDICA SUBSP. ISLANDICA, COCHINEAL, COPPER, DROSERA ROTUNDIFOLIA, ECHINACEA ANGUSTIFOLIA, PLANTAGO MAJOR, LOBARIA PULMONARIA, THYME
Label structure10 sections

Indications and uses

Relieves dry and wet cough Helps reduce mucus and phlegm

Dosage and administration

Use enclosed dosage cup for dosing Adults and children 12 years and older 10 ml every 4 hours as needed Children between 12 years and 2 years of age 5 ml every 4 hours as needed Children under 2 years Ask a physician

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS/PURPOSE

OTC - ACTIVE INGREDIENT SECTION

ALTHAEA OFFICINALIS 1X SOOTHING

ANTIMONIUM TARTARICUM 8X EXPECTORANT

CETRARIA ISLANDICA 4X EXPECTORANT

COCCUS CACTI 6X RELIEVES COUGH

PLANTAGO MAJOR 1X RELIEVES SORE THROAT

BRYONIA 6X RELIEVES DRY COUGH

CUPRUM ACETICUM 8X RELIEVES COUGH

DROSERA 1X RELIEVES DRY COUGH

ECHINACEA 1X SOOTHING

STICTA PULMONARIA 4X EXPECTORANT

THYME 1X SOOTHING

USES

OTC - PURPOSE SECTION

  • Relieves dry and wet cough
  • Helps reduce mucus and phlegm

WARNINGS

WARNINGS SECTION

Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema or is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
If pregnant or breast-feeding ask a health care professional before use.
Keep out of reach of children.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately

PREGNANCY

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ask a doctor before use

WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medicines out of reach of children

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Use enclosed dosage cup for dosing

Adults and children 12 years and older 10 ml every 4 hours as needed

Children between 12 years and 2 years of age 5 ml every 4 hours as needed

Children under 2 years Ask a physician

QUESTIONS

OTC - QUESTIONS SECTION

Questions?: info@gunainc.com
Tel. (484) 223-3500

INDICATIONS & USAGE SECTION

Directions: use enclosed cup for dosing.

INACTIVE INGREDIENT SECTION

Inactive ingredients: purified water, fructose syrup, hydroxypropyl methylcellulose, potassium sorbate, sodium benzoate, cherry flavor.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5USOMT5USOMT

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17089-453-242020-03-13C16284748780-19d75b9d0-485b-f424-e053-dadaa90a57ceGUNA-COUGH
17089-453-242020-01-31C16284748780-19d75b9d0-485b-f424-e053-dadaa90a57ceGUNA-COUGH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17089-453-24GUNA-COUGH150 mL in 1 BOTTLESOLUTION/ DROPS1507
17089-453-24GUNA-COUGH1 in 1 BOXSOLUTION/ DROPS17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17089-453GUNA-COUGH (ALTHAEA OFFICINALIS LEAF - ANTIMONY POTASSIUM TARTRATE - BRYONIA ALBA ROOT - CETRARIA ISLANDICA SUBSP. ISLANDICA - COCHINEAL - COPPER - DROSERA ROTUNDIFOLIA - ECHINACEA ANGUSTIFOLIA - GARDEN THYME - LOBARIA PULMONARIA - PLANTAGO MAJOR -) SOLUTION/ DROPS [GUNA SPA]7Current NDC, Legacy NDC, 2 package rows20201024_40e9509c-5cc2-4077-ab89-34bec9015f42.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALTHAEA OFFICINALIS LEAFACTIVE INGREDIENTE2QQV923381
ANTIMONY POTASSIUM TARTRATEACTIVE INGREDIENTDL6OZ476V31
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2B1
CETRARIA ISLANDICA SUBSP. ISLANDICAACTIVE INGREDIENTBJ7YPN79A11
COCHINEALACTIVE INGREDIENTTZ8Z31B35M1
COPPERACTIVE INGREDIENT789U1901C51
DROSERA ROTUNDIFOLIAACTIVE INGREDIENT75O014T1HG1
ECHINACEA ANGUSTIFOLIAACTIVE INGREDIENTVB06AV5US81
LOBARIA PULMONARIAACTIVE INGREDIENTD1YM0P5Z2T1
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6U1
THYMEACTIVE INGREDIENTCW657OBU4N1
ALTHAEA OFFICINALIS LEAFACTIVE MOIETYE2QQV923381
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2B1
CETRARIA ISLANDICA SUBSP. ISLANDICAACTIVE MOIETYBJ7YPN79A11
COCHINEALACTIVE MOIETYTZ8Z31B35M1
COPPERACTIVE MOIETY789U1901C51
DROSERA ROTUNDIFOLIAACTIVE MOIETY75O014T1HG1
ECHINACEA ANGUSTIFOLIAACTIVE MOIETYVB06AV5US81
LOBARIA PULMONARIAACTIVE MOIETYD1YM0P5Z2T1
PLANTAGO MAJORACTIVE MOIETYW2469WNO6U1
TARTARIC ACIDACTIVE MOIETYW4888I119H1
THYMEACTIVE MOIETYCW657OBU4N1
FRUCTOSEINACTIVE INGREDIENT6YSS42VSEV1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WO1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17089-45317089-453-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 114 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii+route
26 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii+route
38 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4POWDER, FOR SUSPENSION / ORAL19 mgExact identifier — unii+route
26 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii+route
16 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CONCENTRATE / ORAL1 mgExact identifier — unii+route
26 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSUSPENSION / ORAL20 mg/1mlExact identifier — unii+route
16 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOCAPSULE, DELAYED RELEASE / ORAL105 mgExact identifier — unii+route
34 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CONCENTRATE / ORAL1 mgExact identifier — unii+route
26 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route
38 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVPOWDER, FOR SUSPENSION / ORAL6000 mgExact identifier — unii+route
16 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, COATED / ORALNAExact identifier — unii+route
26 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVTABLET / ORAL64.92 mgExact identifier — unii+route
16 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii+route
38 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOCAPSULE / ORAL1488 mgExact identifier — unii+route
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii+route
38 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii+route
26 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii+route
38 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route
34 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOSYRUP / ORAL250 mgExact identifier — unii+route
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii+route
38 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSYRUP / ORAL1732.5 mg/5mlExact identifier — unii+route
16 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii+route
38 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOCAPSULE, DELAYED RELEASE / ORAL105 mgExact identifier — unii+route
34 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SOLUTION / ORAL98 mgExact identifier — unii+route
38 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii+route
34 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, COATED / ORALNAExact identifier — unii+route
26 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route
34 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSUSPENSION / ORAL20 mg/1mlExact identifier — unii+route
16 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii+route
38 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CAPSULE / ORALNAExact identifier — unii+route
26 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4GRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii+route
26 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET / ORAL6 mgExact identifier — unii+route
26 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii+route
38 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOSYRUP / ORAL250 mgExact identifier — unii+route
34 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, FILM COATED, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii+route
26 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii+route
38 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOCAPSULE, COATED PELLETS / ORAL3.32 mgExact identifier — unii+route
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii+route
38 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, FILM COATED, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii+route
26 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4PASTE / ORAL48 mgExact identifier — unii+route
26 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOGRANULE, FOR SUSPENSION / ORAL1.7 mgExact identifier — unii+route
34 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOTABLET, ORALLY DISINTEGRATING / ORAL41 mgExact identifier — unii+route
34 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOGRANULE / ORAL45 mgExact identifier — unii+route
34 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii+route
16 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route
34 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SUSPENSION / ORAL400 mgExact identifier — unii+route
26 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii+route
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii+route
38 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOCAPSULE, EXTENDED RELEASE / ORAL119.7 mgExact identifier — unii+route
34 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOTABLET, ORALLY DISINTEGRATING / ORAL41 mgExact identifier — unii+route
34 equally ranked IID candidates
FRUCTOSEFRUCTOSE6YSS42VSEVSYRUP / ORAL1732.5 mg/5mlExact identifier — unii+route
16 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii+route
38 equally ranked IID candidates

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
GUNA-COUGHALTHAEA OFFICINALIS LEAF - ANTIMONY POTASSIUM TARTRATE - BRYONIA ALBA ROOT - CETRARIA ISLANDICA SUBSP. ISLANDICA - COCHINEAL - COPPER - DROSERA ROTUNDIFOLIA - ECHINACEA ANGUSTIFOLIA - GARDEN THYME - LOBARIA PULMONARIA - PLANTAGO MAJOR -Guna spa40e9509c-5cc2-4077-ab89-34bec9015f422020-10-23WarningsExact identifier
ndc (package): 17089-453-24
ndc (product): 17089-453
ndc11 (package): 17089045324
spl id: b2576e8c-11d8-1d15-e053-2a95a90a72b1
spl set id: 40e9509c-5cc2-4077-ab89-34bec9015f42

Reported adverse events (FAERS/openFDA)#

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