Cough - airway liquid

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

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 0 to 11, give 3 drops) as needed or as directed by 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.

Ingredients and appearance - Product information

Cough - airway liquid- 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

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 55714-2414
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Influenza a virus ( UNII: R9HH0NDE2E)( Influenza a virus - UNII: R9HH0NDE2E ) 30 [hp_X]in 1 mL
Antimony potassium tartrate ( UNII: DL6OZ476V3)( Antimony cation (3+) - UNII: 069647RPT5 ) 15 [hp_X]in 1 mL
Arsenic trioxide ( UNII: S7V92P67HO)( Arsenic cation (3+) - UNII: C96613F5AV ) 15 [hp_X]in 1 mL
Bryonia alba root ( UNII: T7J046YI2B)( Bryonia alba root - UNII: T7J046YI2B ) 15 [hp_X]in 1 mL
Chelidonium majus ( UNII: 7E889U5RNN)( Chelidonium majus - UNII: 7E889U5RNN ) 15 [hp_X]in 1 mL
Cinchona officinalis bark ( UNII: S003A158SB)( Cinchona officinalis bark - UNII: S003A158SB ) 15 [hp_X]in 1 mL
Drosera rotundifolia flowering top ( UNII: 75O014T1HG)( Drosera rotundifolia flowering top - UNII: 75O014T1HG ) 15 [hp_X]in 1 mL
Eucalyptus globulus leaf ( UNII: S546YLW6E6)( Eucalyptus globulus leaf - UNII: S546YLW6E6 ) 15 [hp_X]in 1 mL
Histamine dihydrochloride ( UNII: 3POA0Q644U)( Histamine - UNII: 820484N8I3 ) 15 [hp_X]in 1 mL
Goldenseal ( UNII: ZW3Z11D0JV)( Goldenseal - UNII: ZW3Z11D0JV ) 15 [hp_X]in 1 mL
Potassium dichromate ( UNII: T4423S18FM)( Dichromate ion - UNII: 9LKY4BFN2V ) 15 [hp_X]in 1 mL
Potassium carbonate ( UNII: BQN1B9B9HA)( Carbonate ion - UNII: 7UJQ5OPE7D ) 15 [hp_X]in 1 mL
Potassium iodide ( UNII: 1C4QK22F9J)( Iodide ion - UNII: 09G4I6V86Q ) 15 [hp_X]in 1 mL
Myrrh ( UNII: JC71GJ1F3L)( Myrrh - UNII: JC71GJ1F3L ) 15 [hp_X]in 1 mL
Sodium sulfate ( UNII: 0YPR65R21J)( Sodium sulfate anhydrous - UNII: 36KCS0R750 ) 15 [hp_X]in 1 mL
Strychnos nux-vomica seed ( UNII: 269XH13919)( Strychnos nux-vomica seed - UNII: 269XH13919 ) 15 [hp_X]in 1 mL
Phosphorus ( UNII: 27YLU75U4W)( Phosphorus - UNII: 27YLU75U4W ) 15 [hp_X]in 1 mL
Pulsatilla vulgaris ( UNII: I76KB35JEV)( Pulsatilla vulgaris - UNII: I76KB35JEV ) 15 [hp_X]in 1 mL
Rumex crispus root ( UNII: 9N1RM2S62C)( Rumex crispus root - UNII: 9N1RM2S62C ) 15 [hp_X]in 1 mL
Sambucus nigra flowering top ( UNII: CT03BSA18U)( Sambucus nigra flowering top - UNII: CT03BSA18U ) 15 [hp_X]in 1 mL
Spongia officinalis skeleton, roasted ( UNII: 1PIP394IID)( Spongia officinalis skeleton, roasted - UNII: 1PIP394IID ) 15 [hp_X]in 1 mL
Tussilago farfara ( UNII: 0JXZ63016V)( Tussilago farfara - UNII: 0JXZ63016V ) 15 [hp_X]in 1 mL
Verbascum thapsus ( UNII: C9TD27U172)( Verbascum thapsus - UNII: C9TD27U172 ) 15 [hp_X]in 1 mL
Echinacea, unspecified ( UNII: 4N9P6CC1DX)( Echinacea, unspecified - UNII: 4N9P6CC1DX ) 6 [hp_X]in 1 mL
Arctium lappa root ( UNII: 597E9BI3Z3)( Arctium lappa root - UNII: 597E9BI3Z3 ) 6 [hp_X]in 1 mL
Influenza b virus ( UNII: 1314JZ2X6W)( Influenza b virus - UNII: 1314JZ2X6W ) 30 [hp_X]in 1 mL

Inactive Ingredients

Ingredient Name Code
Alcohol ( UNII: 3K9958V90M)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 55714-2414-1 30mL in 1 BOTTLE, GLASS 2019/01/31
2 NDC: 55714-2414-2 50mL in 1 BOTTLE, GLASS 2019/01/31
3 NDC: 55714-2414-0 15mL in 1 BOTTLE, GLASS 2019/01/31

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved homeopathic USA 2019/01/31

Labeler - Newton Laboratories, Inc.( 788793610)

Establishment

Name ID/FEI Business Operations
Newton Laboratories, Inc. 788793610 manufacture( 55714-2414)

Package label