HANGOVER HELP- agaricus musc., arsenicum alb., bismuthum metallicum, bryonia, capsicum, carbo veg., glonoinum, ipecac., iris versicolor, laurocerasus, lycopodium, mezereum, nux vom., pulsatilla, ranunc. bulb. , theridion, veratrum alb., zinc. met., zingiber, chamomilla, passiflora, valeriana liquid 
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Hangover 2450L

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Adults, take 6 drops by mouth 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

Equal parts of Chamomilla 6x, Passiflora 6x, Valeriana 6x, 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.

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 alcohol 20%.

QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

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

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package label

HANGOVER HELP 
agaricus musc., arsenicum alb., bismuthum metallicum, bryonia, capsicum, carbo veg., glonoinum, ipecac., iris versicolor, laurocerasus, lycopodium, mezereum, nux vom., pulsatilla, ranunc. bulb. , theridion, veratrum alb., zinc. met., zingiber, chamomilla, passiflora, valeriana liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2450
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA FRUITING BODY15 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE15 [hp_X]  in 1 mL
BISMUTH (UNII: U015TT5I8H) (BISMUTH - UNII:U015TT5I8H) BISMUTH15 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM15 [hp_X]  in 1 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL15 [hp_X]  in 1 mL
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN15 [hp_X]  in 1 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC15 [hp_X]  in 1 mL
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT15 [hp_X]  in 1 mL
PRUNUS LAUROCERASUS LEAF (UNII: F26P2D4757) (PRUNUS LAUROCERASUS LEAF - UNII:F26P2D4757) PRUNUS LAUROCERASUS LEAF15 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE15 [hp_X]  in 1 mL
DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK15 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED15 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA15 [hp_X]  in 1 mL
RANUNCULUS BULBOSUS (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS15 [hp_X]  in 1 mL
THERIDION CURASSAVICUM (UNII: 9Z8D3HEM8L) (THERIDION CURASSAVICUM - UNII:9Z8D3HEM8L) THERIDION CURASSAVICUM15 [hp_X]  in 1 mL
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT15 [hp_X]  in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC15 [hp_X]  in 1 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER15 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP6 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-2450-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-2450)

Revised: 1/2020
Document Id: 9bcd43b4-68f5-3804-e053-2995a90a1ff7
Set id: 9bcce2ee-42c2-29cf-e053-2a95a90a3639
Version: 1
Effective Time: 20200110
 
Newton Laboratories, Inc.