Label: PEDIATRIC EARACHE REMEDY- ear drops liquid
- NDC Code(s): 64616-050-01, 64616-050-02
- 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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- Pediatric Earache Remedy
- Pediatric Earache Remedy
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Pediatric Earache Remedy
Keep this and all medicines out of reach of children. Before use with children under 3 years of age, or if you are pregnant or nursing, seek the advice of you health care professional. Avoid contact with eyes. If symptoms persist for more than 4 days, or if there is discharge from the ear or perforation, discontinue use and contact your health care professional. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. All the ingredients are edible but they are not intended for internal use.
- Pediatric Earache Remedy
- Pediatric Earache Remedy
- Pediatric Earache Remedy
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Pediatric Earache Remedy
Aconitum napellus - relieves earach, hot, painful, swollen ear.
Belladonna - relieves otitis media, throbbing deep ear pain.
Chamomilla - relieves earache, soreness, swelling, otalgia.
Kali mur - relieves chronic catarrahal conditions of middle ear.
Plantago major - relieves earache, neuralgic earache, otalgia
Verbascum - Relieves catarrhs, otalgia with sense of obstruction.
- Pediatric Earache Remedy
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INGREDIENTS AND APPEARANCE
PEDIATRIC EARACHE REMEDY
ear drops liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64616-050 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 6 [hp_X] in 1 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 3 [hp_X] in 1 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 3 [hp_X] in 1 mL PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR 3 [hp_X] in 1 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 6 [hp_X] in 1 mL VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength GRAPEFRUIT (UNII: O82C39RR8C) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64616-050-02 1 in 1 CARTON 07/30/2007 1 NDC:64616-050-01 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/23/2006 Labeler - Vitality Works, Inc (137752817) Registrant - Vitality Works, Inc. (137752817) Establishment Name Address ID/FEI Business Operations Vitality Works, Inc. 137752817 manufacture(64616-050)
