Label: OTITIS MEDIA DROPS 2153- otitis media drops liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 63083-2153-2 - 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- QUESTIONS
- INDICATIONS
- PURPOSE
-
WARNINGS
Persistent symptoms may be a sign of a serious condition. If symptoms persist or are accompanied by a fever, persistent headache, or loss of hearing, 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.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- LABEL
-
INGREDIENTS AND APPEARANCE
OTITIS MEDIA DROPS 2153
otitis media drops liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63083-2153 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 3 [hp_X] in 59 mL PULSATILLA MONTANA WHOLE (UNII: 24K790T39B) (PULSATILLA MONTANA WHOLE - UNII:24K790T39B) PULSATILLA MONTANA WHOLE 4 [hp_X] in 59 mL ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS WHOLE - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE 6 [hp_X] in 59 mL SUS SCROFA EAR (UNII: 7DX2J287CV) (SUS SCROFA EAR - UNII:7DX2J287CV) SUS SCROFA EAR 6 [hp_X] in 59 mL AMARYLLIS BELLADONNA WHOLE (UNII: 11B89M58UN) (AMARYLLIS BELLADONNA WHOLE - UNII:11B89M58UN) AMARYLLIS BELLADONNA WHOLE 12 [hp_X] in 59 mL TELLURIUM (UNII: NQA0O090ZJ) (TELLURIUM - UNII:NQA0O090ZJ) TELLURIUM 12 [hp_X] in 59 mL FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE 12 [hp_X] in 59 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 30 [hp_X] in 59 mL MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY 30 [hp_X] in 59 mL STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (STREPTOCOCCUS PNEUMONIAE - UNII:BT6U234YR2) STREPTOCOCCUS PNEUMONIAE 30 [hp_X] in 59 mL HAEMOPHILUS INFLUENZAE (UNII: K738E2MB3I) (HAEMOPHILUS INFLUENZAE - UNII:K738E2MB3I) HAEMOPHILUS INFLUENZAE 60 [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:63083-2153-2 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(63083-2153)
