FDA.reportPublic FDA data

Cough - Airway

Manufacturer
Newton Laboratories, Inc.
Effective date
2022-03-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:17:10

Label at a glance#

ProductCough - Airway
Active ingredientINFLUENZA A VIRUS, ANTIMONY POTASSIUM TARTRATE, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS BARK, DROSERA ROTUNDIFOLIA FLOWERING TOP, POTASSIUM DICHROMATE, EUCALYPTUS GLOBULUS LEAF, HISTAMINE DIHYDROCHLORIDE, GOLDENSEAL, POTASSIUM CARBONATE, POTASSIUM IODIDE, MYRRH, PULSATILLA VULGARIS, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, RUMEX CRISPUS ROOT, SAMBUCUS NIGRA FLOWERING TOP, SPONGIA OFFICINALIS SKELETON, ROASTED, TUSSILAGO FARFARA, VERBASCUM THAPSUS, ECHINACEA, UNSPECIFIED, ARCTIUM LAPPA ROOT, INFLUENZA B VIRUS
Label structure10 sections

Label contents#

Full prescribing information#

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OTC - PREGNANCY OR BREAST FEEDING SECTION

If ​pregnant or breast-feeding,​ ask a doctor before use.

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

OTC - PURPOSE SECTION

Formulated for symptoms such as wheezing, shortness of breath, congestion, coughing, dryness and painful breathing.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Lappa 6x, Antimon. tart. 15x, Arsenicum alb. 15x, Bryonia 15x, Chelidonium majus 15x, Cinchona 15x, Drosera 15x, Eucalyptus 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Kali carb. 15x, Kali iod. 15x, Myrrha 15x, Nat. sulphuricum 15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Rumex crisp. 15x, Sambucus nig.15x, Spongia 15x, Tussilago farfara 15x, Verbascum 15x, Influenzinum 30x.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 4 to 11, give 3 drops) as needed or as directed by a health professional. Under age 4, consult a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

INDICATIONS & USAGE SECTION

Formulated for symptoms such as wheezing, shortness of breath, congestion, coughing, dryness and painful breathing.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2414-0Cough - Airway15 mL in 1 BOTTLE, GLASSLIQUID154
55714-2414-1Cough - Airway30 mL in 1 BOTTLE, GLASSLIQUID304
55714-2414-2Cough - Airway50 mL in 1 BOTTLE, GLASSLIQUID504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2414COUGH - AIRWAY (INFLUENZA A VIRUS, INFLUENZA B VIRUS, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB.,KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPA) LIQUID [NEWTON LABORATORIES, INC.]4Current NDC, Legacy NDC, 3 package rows20220318_92ae84ae-559c-79b8-e053-2a95a90aa79f.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-241455714-2414-1, 55714-2414-2, 55714-2414-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
INFLUENZA A VIRUSR9HH0NDE2EACTIB
ANTIMONY POTASSIUM TARTRATEDL6OZ476V3ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
DROSERA ROTUNDIFOLIA FLOWERING TOP75O014T1HGACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
EUCALYPTUS GLOBULUS LEAFS546YLW6E6ACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
GOLDENSEALZW3Z11D0JVACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
POTASSIUM IODIDE1C4QK22F9JACTIM
MYRRHJC71GJ1F3LACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SODIUM SULFATE0YPR65R21JACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
RUMEX CRISPUS ROOT9N1RM2S62CACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
TUSSILAGO FARFARA0JXZ63016VACTIB
VERBASCUM THAPSUSC9TD27U172ACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
ARCTIUM LAPPA ROOT597E9BI3Z3ACTIB
INFLUENZA B VIRUS1314JZ2X6WACTIB
WATER059QF0KO0RIACT

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
Cough - AirwayINFLUENZA A VIRUS, INFLUENZA B VIRUS, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB.,KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPANewton Laboratories, Inc.92ae84ae-559c-79b8-e053-2a95a90aa79f2022-03-17WarningsExact identifier
ndc (package): 55714-2414-2
ndc (package): 55714-2414-0
ndc (package): 55714-2414-1
ndc (product): 55714-2414
ndc11 (package): 55714241402
ndc11 (package): 55714241401
ndc11 (package): 55714241400
spl id: da7041b6-092f-6531-e053-2995a90a712d
spl set id: 92ae84ae-559c-79b8-e053-2a95a90aa79f

Reported adverse events (FAERS/openFDA)#

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