Label: 4 KIDS EARACHE RELIEF- matricaria chamomilla,ferric phosphate,sulfur,oyster shell calcium carbonate, crude,lycopodium clavatum spore and anemone pulsatilla tablet
- NDC Code(s): 54973-3393-1
- Packager: Hyland's 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 November 22, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Drug Facts
Active ingredients
Calcarea Carbonica 30C HPUS
Chamomilla 30C HPUS
Ferrum Phosphoricum 30C HPUS
Lycopodium 30C HPUS
Pulsatilla 30C HPUS
Sulphur 30C HPUS
“HPUS” indicates that the active ingredients are in the official Homeopathic
Pharmacopœia of the United States.
Purpose
Calcarea Carbonica 30C HPUS.....................................................throbbing ear pain
Chamomilla 30C HPUS ...............................occasional sleeplessness and irritability
Ferrum Phosphoricum 30C HPUS...........................................................minor fever
Lycopodium 30C HPUS................................................................................ear pain
Pulsatilla 30C HPUS.............................ear itching, pain worse at night, minor fever
Sulphur 30C HPUS...............................................ear pain with burning, minor fever
- Uses
-
Warnings
Consult a physician if
- symptoms persist for more than 48 hours or worsen.
- discharge from ear is present.
- symptoms are accompanied by a high fever (over 101ºF).
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Directions
Children 2 years
to under 6 years
Dissolve 2 tablets under tongue every 8 hours
until relieved for up to 48 hours.
Children 6 years
to under 12 years
Dissolve 3 tablets under tongue every 8 hours
until relieved for up to 48 hours.
Adults and children
12 years and over
Dissolve 4 tablets under tongue every 8 hours
until relieved for up to 48 hours.
- Inactive ingredients
- Questions or comments?
- Principal Display Panel - 40 Tablets Bottle Carton
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INGREDIENTS AND APPEARANCE
4 KIDS EARACHE RELIEF
matricaria chamomilla,ferric phosphate,sulfur,oyster shell calcium carbonate, crude,lycopodium clavatum spore and anemone pulsatilla tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3393 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 30 [hp_C] FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE 30 [hp_C] LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 30 [hp_C] ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 30 [hp_C] OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_C] SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 30 [hp_C] Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) Product Characteristics Color white (to Off-White) Score no score Shape ROUND Size 9mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3393-1 1 in 1 CARTON 12/01/2018 1 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/01/2018 Labeler - Hyland's Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-3393) , pack(54973-3393) , label(54973-3393)
