| NDC | 54973-3324-1, 54973-3324-4 |
| Set ID | 58ef86b7-5b38-1591-e053-2991aa0aa53e |
| Category | HUMAN OTC DRUG LABEL |
| Packager | HYLAND'S |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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Drug Facts
Active ingredients
Arnica Montana 30X HPUS
Calcarea Carbonica 12X HPUS
Calcarea Phosphorica 12X HPUS
Chamomilla 12X HPUS
Coffea Cruda 6X HPUS
Ferrum Phosphoricum 12X HPUS
Magnesia Phosphorica 12X HPUS
Silicea 12X HPUS
“HPUS” indicates that the active ingredients are in the official Homeopathic
Pharmacopoeia of the United States.
- Uses
-
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
If child is restless or wakeful during the night,
dissolve 1 tablet on tongue every 15 minutes for
4 doses, then hourly until relieved.
Children 6 months to
3 years of age
If child is restless or wakeful during the night, dissolve
2 tablets on tongue every 15 minutes for 4 doses, then
hourly until relieved.
Hyland’s Baby Nighttime Oral Pain Relief Tablets are very soft and will dissolve
instantly in the mouth.
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL-125 TABLET BOTTLE CARTON
NDC 54973-3324-1
HOMEOPATHIC
Natural
Relief
SINCE 1903
Hyland's
Baby
Nighttime
Oral Pain
Relief*
RELIEF OF PAIN,
IRRITABILITY, SWELLING, AND
OCCASIONAL SLEEPLESSNESS
DUE TO ORAL DISCOMFORT
► No Belladonna, Benzocaine, Artificial Flavors,
Dyes or Parabens
125 QUICK-DISSOLVING TABLETS
ACTUAL SIZE 65 MG
-
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 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(54973-3324) , pack(54973-3324) , label(54973-3324)