FORMULA 3 COUGH SYRUP- cough syrup liquid 
Vitality Works, 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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Formula 3 Cough Syrup

Formula 3 Cough Syrup

Unckaloabo (Pelargonium sidoides) 1X

Wild Cherry Bark (Prunus serotina) 1X

European Elderberry (Sambucus nigra) 1X

Formula 3 Cough Syrup

Buckwheat Honey, Elderberry Extract, Citric Acid, USP Purified Water, Natural Mixed Berry and Raspberry Flavor, Potassium Sorbate, Stevia, Xanthan Gum

Formula 3 Cough Syrup

Do not give product for persistent or chronic cough such as occurs with asthma or if cough is accompanied excessive phlegm (mucus) unless directed by doctor. Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, as a persistent cough may be a sign of a serious condition. If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Formula 3 Cough Syrup

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Formula 3 Cough Syrup

Temprarily relieves symptoms of cough including dryness and minor throat and bronchial irritation associated with the common cold.

Formula 3 Cough Syrup

Umckaloabo - Cough Suppressant

Wild Cherry Bark - Cough Suppressant

European Elderberry - Cough Suppressant

Formula 3 Cough Formula

- Children 2 to 4 years of age:  1/2 teaspoon every 3 hours, or as needed.

- Children 5 to 11 years of age:  1 teaspoon every 3 hours, or as needed.

Children under 2 years of age:  Consult your healthcare practitioner

Formula 3 Cough Formula

Label

FORMULA 3 COUGH SYRUP 
cough syrup liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64616-072
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT1 [hp_X]  in 1 mL
PRUNUS SEROTINA BARK (UNII: 5D48E975HA) (PRUNUS SEROTINA BARK - UNII:5D48E975HA) PRUNUS SEROTINA BARK1 [hp_X]  in 1 mL
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) SAMBUCUS NIGRA FLOWER1 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HONEY (UNII: Y9H1V576FH)  
AMERICAN ELDERBERRY (UNII: 7610Y219OC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
STEVIA LEAF (UNII: 6TC6NN0876)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorRASPBERRY (RASPBERRY NATURAL FLAVOR) , BERRY (MIXED BERRY NATURAL FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64616-072-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/07/2010
Labeler - Vitality Works, Inc. (137752817)
Registrant - Vitality Works, Inc (137752817)
Establishment
NameAddressID/FEIBusiness Operations
Vitality Works, Inc137752817manufacture(64616-072)

Revised: 12/2023
Document Id: 0d9b8bfc-62d9-3e8f-e063-6294a90a373b
Set id: 199bbe91-ebfe-45fa-acba-62b35c7e6fba
Version: 7
Effective Time: 20231228
 
Vitality Works, Inc.