Label: BABY NIGHTTIME ORAL PAIN RELIEF- arnica montana, tribasic calcium phosphate, matricaria chamomilla, silicon dioxide, magnesium phosphate, dibasic trihydrate, ferrosoferric phosphate, arabica coffee bean and oyster shell calcium carbonate, crude tablet
- NDC Code(s): 54973-3324-1, 54973-3324-4
- 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 January 17, 2023
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 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 Magnesia Phosphorica 12X HPUS oral pain, occasional sleeplessness Silicea 12X HPUS oral pain at night, occasional sleeplessness "HPUS" is the Homeopathic Pharmacopoeia of the United States.
- Uses
- Warnings
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Directions
■ Use as directed.
Children under
6 monthsAt onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,
2 tablets every 4 hours during the night until relieved.Children 6 months
to under 3 yearsAt onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,
3 tablets every 4 hours during the night 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 NIGHTTIME ORAL PAIN RELIEF
arnica montana, tribasic calcium phosphate, matricaria chamomilla, silicon dioxide, magnesium phosphate, dibasic trihydrate, ferrosoferric phosphate, arabica coffee bean and oyster shell calcium carbonate, crude tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3324 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 MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 12 [hp_X] in 1 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [hp_X] in 1 g ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 30 [hp_X] in 1 g FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC 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 MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) ACACIA (UNII: 5C5403N26O) Product Characteristics Color 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:54973-3324-1 1 in 1 CARTON 08/17/2017 1 1 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3324-4 6 g in 1 PACKET; Type 0: Not a Combination Product 08/17/2017 12/27/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/17/2017 Labeler - Hyland' Inc. (008316655)