BABY ORAL PAIN RELIEF- oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla tablet

Baby Oral Pain Relief by

Drug Labeling and Warnings

Baby Oral Pain Relief by is a Homeopathic medication manufactured, distributed, or labeled by Hyland' Inc., Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Temporarily relieves the symptoms of: gum sensitivity, swelling or soreness of gums, oral pain or discomfort.

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.

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Do not use if imprinted tamper-evident bottle cap band is broken or missing.

The inner packaged bottle is child-resistant.In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

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

Acacia Gum, Lactose

Questions or comments?

(800) 624-9659.

PURPOSE

Relief of pain, irritability and swelling due to oral discomfort

PRINCIPAL DISPLAY PANEL-125 TABLET BOTTLE CARTON

NDC: 54973-3315-1

HOMEOPATHIC

Natural

Relief

SINCE 1903

Hyland's

Baby

Daytime

Oral Pain

Relief*

RELIEF OF PAIN,

IRRITABILITY, AND SWELLING

DUE TO ORAL DISCOMFORT

No Belladonna, Benzocaine, Artificial Flavors,

Dyes or Parabens

125 QUICK-DISSOLVING TABLETS

ACTUAL SIZE 65 MG

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 tablet

Product 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
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'S (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
STANDARD HOMEOPATHIC COMPANY		008316655	manufacture(54973-3315) , pack(54973-3315) , label(54973-3315)