Label: COLD AND FLU FORMULA 2109- cold and flu formula liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 63083-2109-2 - Packager: Professional Complementary Health Formulas
- 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 August 15, 2019
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- ACTIVE INGREDIENTS
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WARNINGS
Persistent symptoms may be a sign of a serious condition. If symptoms persist or are accompanied by a fever, rash, or persistent headache, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.
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DIRECTIONS
Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age.
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INGREDIENTS AND APPEARANCE
COLD AND FLU FORMULA 2109
cold and flu formula liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63083-2109 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER 2 [hp_X] in 59 mL MENTHA PULEGIUM WHOLE (UNII: 5Q6Y7K4846) (MENTHA PULEGIUM WHOLE - UNII:5Q6Y7K4846) MENTHA PULEGIUM WHOLE 3 [hp_X] in 59 mL LONICERA HYPOGLAUCA FLOWER (UNII: 3ADI26ATFY) (LONICERA HYPOGLAUCA FLOWER - UNII:3ADI26ATFY) LONICERA HYPOGLAUCA FLOWER 3 [hp_X] in 59 mL STACHYURUS CHINENSIS WHOLE (UNII: 1LS938417A) (STACHYURUS CHINENSIS WHOLE - UNII:1LS938417A) STACHYURUS CHINENSIS WHOLE 3 [hp_X] in 59 mL FORSYTHIA SUSPENSA FRUIT (UNII: P4793M1ES5) (FORSYTHIA SUSPENSA FRUIT - UNII:P4793M1ES5) FORSYTHIA SUSPENSA FRUIT 3 [hp_X] in 59 mL ARCTIUM LAPPA FRUIT (UNII: EA541308MV) (ARCTIUM LAPPA FRUIT - UNII:EA541308MV) ARCTIUM LAPPA FRUIT 3 [hp_X] in 59 mL ASTRAGALUS PROPINQUUS ROOT (UNII: 922OP8YUPF) (ASTRAGALUS PROPINQUUS ROOT - UNII:922OP8YUPF) ASTRAGALUS PROPINQUUS ROOT 6 [hp_X] in 59 mL BOS TAURUS PLACENTA (UNII: 83AL37E3A7) (BOS TAURUS PLACENTA - UNII:83AL37E3A7) BOS TAURUS PLACENTA 6 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63083-2109-2 59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 08/15/1985 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/15/1984 Labeler - Professional Complementary Health Formulas (167339027) Registrant - Natural Pharmaceutical Manufacturing LLC (015624923) Establishment Name Address ID/FEI Business Operations Natural Pharmaceutical Manufacturing LLC 015624923 manufacture(63083-2109)