FDA.reportPublic FDA data

Hangover Help

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:44:24

Label at a glance#

ProductHangover Help
Active ingredientAmanita Muscaria Var. Muscaria Fruiting Body, Arsenic Trioxide, Bismuth, Bryonia Alba Root, Capsicum, Activated Charcoal, Nitroglycerin, Ipecac, Iris Versicolor Root, Prunus Laurocerasus Leaf, Lycopodium Clavatum Spore, Daphne Mezereum Bark, Strychnos Nux-vomica Seed, Pulsatilla Vulgaris, Ranunculus Bulbosus, Theridion Curassavicum, Veratrum Album Root, Zinc, Ginger, Matricaria Recutita, Passiflora Incarnata Flowering Top, Valerian
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Hangover Help   Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Adults, take 6 drops orally as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Agaricus musc. 15x, Arsenicum alb. 15x, Bismuthum metallicum 15x, Bryonia 15x, Capsicum 15x, Carbo veg.15x, Glonoinum 15x, Ipecac. 15x, Iris versicolor 15x, Laurocerasus 15x, Lycopodium 15x, Mezereum 15x, Nux vom. 15x, Pulsatilla 15x, Ranunc. bulb. 15x, Theridion 15x, Veratrum alb. 15x, Zinc. met. 15x, Zingiber 15x, Chamomilla 3x, Passiflora 3x, Valeriana 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-1104-02024-04-09C16284748780-19d75b9d0-eb60-f424-e053-dadaa90a57ceHangover Help
55714-1104-12024-04-09C16284748780-19d75b9d0-eb60-f424-e053-dadaa90a57ceHangover Help
55714-1104-22024-04-09C16284748780-19d75b9d0-eb60-f424-e053-dadaa90a57ceHangover Help
55714-1104-02020-01-31C16284748780-19d75b9d0-eb60-f424-e053-dadaa90a57ceHangover Help
55714-1104-12020-01-31C16284748780-19d75b9d0-eb60-f424-e053-dadaa90a57ceHangover Help
55714-1104-22020-01-31C16284748780-19d75b9d0-eb60-f424-e053-dadaa90a57ceHangover Help

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Activated CharcoalACTIVE INGREDIENT2P3VWU3H101
Amanita Muscaria Var. Muscaria Fruiting BodyACTIVE INGREDIENTDIF093I0371
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
BismuthACTIVE INGREDIENTU015TT5I8H1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
CapsicumACTIVE INGREDIENT00UK7646FG1
Daphne Mezereum BarkACTIVE INGREDIENTX2N6E405GV1
GingerACTIVE INGREDIENTC5529G5JPQ1
IpecacACTIVE INGREDIENT62I3C8233L1
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
Matricaria RecutitaACTIVE INGREDIENTG0R4UBI2ZZ1
NitroglycerinACTIVE INGREDIENTG59M7S0WS31
Passiflora Incarnata Flowering TopACTIVE INGREDIENTCLF5YFS11O1
Prunus Laurocerasus LeafACTIVE INGREDIENTF26P2D47571
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
Ranunculus BulbosusACTIVE INGREDIENTAEQ8NXJ0MB1
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Theridion CurassavicumACTIVE INGREDIENT9Z8D3HEM8L1
ValerianACTIVE INGREDIENTJWF5YAW3QW1
Veratrum Album RootACTIVE INGREDIENTQNS6W5US1Z1
ZincACTIVE INGREDIENTJ41CSQ7QDS1
Activated CharcoalACTIVE MOIETY2P3VWU3H101
Amanita Muscaria Var. Muscaria Fruiting BodyACTIVE MOIETYDIF093I0371
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
BismuthACTIVE MOIETYU015TT5I8H1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
CapsicumACTIVE MOIETY00UK7646FG1
Daphne Mezereum BarkACTIVE MOIETYX2N6E405GV1
GingerACTIVE MOIETYC5529G5JPQ1
IpecacACTIVE MOIETY62I3C8233L1
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
Matricaria RecutitaACTIVE MOIETYG0R4UBI2ZZ1
NitroglycerinACTIVE MOIETYG59M7S0WS31
Passiflora Incarnata Flowering TopACTIVE MOIETYCLF5YFS11O1
Prunus Laurocerasus LeafACTIVE MOIETYF26P2D47571
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
Ranunculus BulbosusACTIVE MOIETYAEQ8NXJ0MB1
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Theridion CurassavicumACTIVE MOIETY9Z8D3HEM8L1
ValerianACTIVE MOIETYJWF5YAW3QW1
Veratrum Album RootACTIVE MOIETYQNS6W5US1Z1
ZincACTIVE MOIETYJ41CSQ7QDS1
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-110455714-1104-1, 55714-1104-2, 55714-1104-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
Amanita Muscaria Var. Muscaria Fruiting BodyDIF093I037ACTIB
Arsenic TrioxideS7V92P67HOACTIB
BismuthU015TT5I8HACTIB
Bryonia Alba RootT7J046YI2BACTIB
Capsicum00UK7646FGACTIB
Activated Charcoal2P3VWU3H10ACTIB
NitroglycerinG59M7S0WS3ACTIB
Ipecac62I3C8233LACTIB
Iris Versicolor RootX43D4L3DQCACTIB
Prunus Laurocerasus LeafF26P2D4757ACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Daphne Mezereum BarkX2N6E405GVACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Ranunculus BulbosusAEQ8NXJ0MBACTIB
Theridion Curassavicum9Z8D3HEM8LACTIB
Veratrum Album RootQNS6W5US1ZACTIB
ZincJ41CSQ7QDSACTIB
GingerC5529G5JPQACTIB
Matricaria RecutitaG0R4UBI2ZZACTIB
Passiflora Incarnata Flowering TopCLF5YFS11OACTIB
ValerianJWF5YAW3QWACTIB
Alcohol3K9958V90MIACT

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 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 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
15b0e6e8-cbd8-8dd6-e063-6294a90a00caf21824ed-9346-e69e-983e-7bdf172b9f0d2024-04-09WarningsExact identifier
spl set id: f21824ed-9346-e69e-983e-7bdf172b9f0d

Reported adverse events (FAERS/openFDA)#

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