FORMULA 3 COUGH SYRUP- cough syrup liquid

Formula 3 Cough Syrup by

Drug Labeling and Warnings

Formula 3 Cough Syrup by is a Homeopathic medication manufactured, distributed, or labeled by Vitality Works, Inc., Vitality Works, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

FORMULA 3 COUGH SYRUP 
cough syrup liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64616-072
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E)	PELARGONIUM SIDOIDES ROOT	1 [hp_X]  in 1 mL
PRUNUS SEROTINA BARK (UNII: 5D48E975HA) (PRUNUS SEROTINA BARK - UNII:5D48E975HA)	PRUNUS SEROTINA BARK	1 [hp_X]  in 1 mL
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T)	SAMBUCUS NIGRA FLOWER	1 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	RASPBERRY (RASPBERRY NATURAL FLAVOR) , BERRY (MIXED BERRY NATURAL FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64616-072-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/07/2010

Labeler - Vitality Works, Inc. (137752817)

Registrant - Vitality Works, Inc (137752817)

Establishment
Name	Address	ID/FEI	Business Operations
Vitality Works, Inc		137752817	manufacture(64616-072)