Label: BABY ORAL PAIN RELIEF- oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla tablet
- NDC Code(s): 54973-3315-1, 54973-3315-3, 54973-3315-7
- Packager: Hyland' 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 1, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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Drug Facts
Active ingredients Purpose Arnica Montana 30X HPUS sore, sensitive or swelling gums Calcarea Carbonica 12X HPUS teething, sore, sensitive or swelling gums Calcarea Phosphorica 12X HPUS teething, sensitive, swelling gums, oral pain Chamomilla 12X HPUS sore, sensitive or swelling gums Coffea Cruda 6X HPUS oral pain, irritability Ferrum Phosphoricum 12X HPUS oral discomfort, swelling gums "HPUS" is the Homeopathic Pharmacopoeia of the United States.
- Uses
- Warnings
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Directions
■ Use as directed.
Children under 6 months At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours. If symptoms persist,
2 tablets every 4 hours until relieved.Children 6 months
to under 3 yearsAt onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist,
3 tablets every 4 hours until relieved. - Inactive ingredients
- Questions?
- *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
- DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
- PURPOSE
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
BABY ORAL PAIN RELIEF
oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3315 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 12 [hp_X] in 1 g TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE 12 [hp_X] in 1 g ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 6 [hp_X] in 1 g ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 30 [hp_X] in 1 g MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 12 [hp_X] in 1 g FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM 12 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) Product Characteristics Color white Score no score Shape ROUND Size 5mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3315-1 1 in 1 CARTON 08/17/2017 1 125 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3315-3 6 g in 1 PACKET; Type 0: Not a Combination Product 08/17/2017 12/27/2021 3 NDC:54973-3315-7 1 in 1 CARTON 08/17/2017 3 80 g 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 08/17/2017 Labeler - Hyland' Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-3315) , pack(54973-3315) , label(54973-3315)
