Complementary 2368L-Dis

Drug Labeling and Warnings

Drug Details [pdf]

COMPLEMENTARY COMPLEX- influenzinum, anthracinum, arnica, belladonna, aconitum nap., arsenicum alb., baptisia, bryonia, hepar sulph. calc., iodium, lachesis, lycopodium, merc. viv., nux vom., phos., pulsatilla, rhus tox., apis mel., echinacea, hydrastis, thuja occ., aaricus musc,. allium sat., aloe, calc. carb., calendula, capiscum, carduus mar., salvia, selenium, taraxacum, tarentula hisp., zinc. met., zingiber 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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Complementary 2368L-Dis

INDICATIONS & USAGE SECTION

Formulated for the immune system.  A complement to organic food, decreased sugar consumption, exercise, detoxification and other supportive homeopathics. 

DOSAGE & ADMINISTRATION SECTION

Directions:  Ages 12 and up, take 6 drops by mouth (ages 0 to11, give 3 drops) three to four times daily or as directed by a health professional.  Sensitive persons begin with 1 drop and gradually increase to full dose.

ACTIVE INGREDIENT SECTION

 Apis mel. 3x, Echinacea 3x, Hydrastis 3x, Thuja occ. 3x, Apis mel. 8x, Echinacea 8x, Hydrastis 8x, Thuja occ. 8x, Aconitum nap. 15x, Agaricus musc. 15x, Allium sat. 15x, Aloe 15x, Arnica 15x, Arsenicum alb. 15x, Azadirachta 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Calc. carb. 15x, Calendula 15x, Capsicum 15x, Carduus mar. 15x, Hepar sulph. calc. 15x, Iodium 15x, Lachesis 15x, Lycopodium 15x, Merc. viv. 15x, Nux vom. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x,. Salvia 15x, Selenium 15x, Taraxacum 15x, Tarentula hisp. 15x, Zinc. met. 15x, Zingiber 15x, Anthracinum 20x, Influenzinum 35x.  

PURPOSE SECTION

Formulated for the immune system.  A complement to organic food, decreased sugar consumption, exercise, detoxification and other supportive homeopathics. 

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

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

WARNINGS SECTION

Warning:  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.

PREGNANCY OR BREAST FEEDING SECTION

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

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package label

COMPLEMENTARY COMPLEX 
influenzinum, anthracinum, arnica, belladonna, aconitum nap., arsenicum alb., baptisia, bryonia, hepar sulph. calc., iodium, lachesis, lycopodium, merc. viv., nux vom., phos., pulsatilla, rhus tox., apis mel., echinacea, hydrastis, thuja occ., aaricus musc,. allium sat., aloe, calc. carb., calendula, capiscum, carduus mar., salvia, selenium, taraxacum, tarentula hisp., zinc. met., zingiber liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55714-2368
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA3 [hp_X]  in 1 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED3 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL3 [hp_X]  in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG3 [hp_X]  in 1 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS10 [hp_X]  in 1 mL
AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA FRUITING BODY10 [hp_X]  in 1 mL
GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC10 [hp_X]  in 1 mL
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE10 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA10 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC CATION (3+)10 [hp_X]  in 1 mL
AZADIRACHTA INDICA BARK (UNII: G580B439YI) (AZADIRACHTA INDICA BARK - UNII:G580B439YI) AZADIRACHTA INDICA BARK10 [hp_X]  in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT10 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA10 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT10 [hp_X]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]  in 1 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP10 [hp_X]  in 1 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM10 [hp_X]  in 1 mL
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE10 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE10 [hp_X]  in 1 mL
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE10 [hp_X]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM10 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE10 [hp_X]  in 1 mL
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY10 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED10 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS10 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]  in 1 mL
SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J) SAGE10 [hp_X]  in 1 mL
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM10 [hp_X]  in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE10 [hp_X]  in 1 mL
LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT) LYCOSA TARANTULA10 [hp_X]  in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC10 [hp_X]  in 1 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER10 [hp_X]  in 1 mL
BACILLUS ANTHRACIS (UNII: IT7Z319PFY) (BACILLUS ANTHRACIS - UNII:IT7Z319PFY) BACILLUS ANTHRACIS15 [hp_X]  in 1 mL
INFLUENZA A VIRUS (UNII: R9HH0NDE2E) (INFLUENZA A VIRUS - UNII:R9HH0NDE2E) INFLUENZA A VIRUS30 [hp_X]  in 1 mL
INFLUENZA B VIRUS (UNII: 1314JZ2X6W) (INFLUENZA B VIRUS - UNII:1314JZ2X6W) INFLUENZA B VIRUS30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55714-2368-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product11/10/201401/31/2019
2NDC: 55714-2368-259 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product11/10/201401/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/10/201401/31/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-2368)

Revised: 10/2019
Document Id: 94194f88-8c5d-5f86-e053-2a95a90a9b29
Set id: 608e0a58-7496-440b-8041-a6af46e7033c
Version: 3
Effective Time: 20191004