![BABY ORAL PAIN RELIEF (OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, ARABICA COFFEE BEAN, ARNICA MONTANA, FERRUM PHOSPHORICUM AND MATRICARIA CHAMOMILLA) TABLET [HYLAND'S]](https://medic.hrt.org//dailymed/images/5904f126-e8f0-a892-e053-2991aa0aef0f/BOPR.jpg)
| NDC | 54973-3315-1, 54973-3315-3 |
| Set ID | 5904f126-e8f0-a892-e053-2991aa0aef0f |
| Category | HUMAN OTC DRUG LABEL |
| Packager | HYLAND'S |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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Drug Facts
Active ingredients
Purpose
Arnica Montana 30X HPUS
sore, sensitive or swelling gums
Calcarea Carbonica 12X HPUS
sore, sensitive or swelling gums Calcarea Phosphorica 12X HPUS
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” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
- Uses
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Warnings
Do not use: • more than directed. • if your child has a known allergy to any ingredient in this product.
Consult a physician if: • symptoms persist for more than 72 hours or worsen. • swelling increases, rash or fever develops. • irritation, pain or redness persists or worsens.
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Directions
Children under 6 months of age: dissolve 1 tablet on tongue every 15 minutes for 4 doses, then hourly until relieved.
Children 6 months to 3 years of age: dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.
Hyland’s Baby Oral Pain Relief Tablets are very soft and will dissolve instantly in the mouth.
- Inactive ingredients
- Questions or comments?
- PURPOSE
- PRINCIPAL DISPLAY PANEL-125 TABLET BOTTLE CARTON
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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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/17/2017 Labeler - HYLAND'S (028570695) Establishment Name Address ID/FEI Business Operations STANDARD HOMEOPATHIC COMPANY 008316655 manufacture(54973-3315) , pack(54973-3315) , label(54973-3315)
