BABY ORAL PAIN RELIEF DROPS- ferrosoferric phosphate,tribasic calcium phosphate,oyster shell calcium carbonate,crude,arnica montana,arabica coffee bean and matricaria chamomilla liquid

Baby Oral Pain Relief Drops by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

“HPUS” indicates that the active ingredients are in the official Homeopathic

Pharmacopœia of the United States.

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

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 foil inner seal 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

• Measure only with the dosing dropper provided.
• Do not use dropper with other products.
• On dosing dropper, mL= milliliter.
• Fill to prescribed level and dispense liquid slowly into baby’s mouth, toward inner cheek.
• For best results, clean dropper after each use with water.

• Newborns and infants under 2 years of age (or weight under 24 lbs.):

  0.3 mL every 15 minutes for up to 8 doses,

  then every 2 hours until relieved.

• Children over 2 years of age (or weight over 24 lbs.):

  0.6 mL every 15 minutes for up to 8 doses,

  then every 2 hours until relieved.

Inactive ingredients

Citric Acid, Glycerine, Potassium Sorbate, Purified Water, Sodium Citrate.

Questions or comments?

(800) 624-9659.

Principal Display Panel - 1 FL. OZ. (29.6 mL) Bottle Carton

New!

NDC: 54973-339-1

HOMEOPATHIC

NATURAL

RELIEF

SINCE 1903

Hyland's

baby

Oral Pain

Relief Drops*

RELIEF OF PAIN,

IRRITABILITY AND SWELLING

DUE TO ORAL DISCONFORT

► No Belladonna, Benzocaine,

Artificial Flavors, Dyes or Parabens

1 FL. OZ (29.6 mL) CONTAINS 0.1% ALCOHOL

INGREDIENTS AND APPEARANCE

BABY ORAL PAIN RELIEF DROPS 
ferrosoferric phosphate,tribasic calcium phosphate,oyster shell calcium carbonate,crude,arnica montana,arabica coffee bean and matricaria chamomilla liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3391
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	30 [hp_X]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	12 [hp_X]  in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR)	TRIBASIC CALCIUM PHOSPHATE	12 [hp_X]  in 1 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	12 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	6 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3391-1	1 in 1 CARTON	01/24/2019
1		29.6 mL 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		01/24/2019

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3391) , pack(54973-3391) , label(54973-3391)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		876754375	manufacture(54973-3391) , pack(54973-3391) , label(54973-3391)