Label: FORMULA 3 COUGH SYRUP- cough syrup liquid
- NDC Code(s): 64616-072-01
- Packager: Vitality Works, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated December 28, 2023
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- Formula 3 Cough Syrup
- Formula 3 Cough Syrup
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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
- Formula 3 Cough Syrup
- Formula 3 Cough Syrup
- Formula 3 Cough Formula
- Formula 3 Cough Formula
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INGREDIENTS AND APPEARANCE
FORMULA 3 COUGH SYRUP
cough syrup liquidProduct 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)
