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

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.

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Baby Oral Pain Relief Drops

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

carton

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3391
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA12 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE12 [hp_X]  in 1 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3391-11 in 1 CARTON01/24/2019
129.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/24/201912/27/2021
Labeler - Hyland's (028570695)
Establishment
NameAddressID/FEIBusiness Operations
Standard Homeopathic Company008316655manufacture(54973-3391) , pack(54973-3391) , label(54973-3391)
Establishment
NameAddressID/FEIBusiness Operations
Applied Laboratories, Inc.876754375manufacture(54973-3391) , pack(54973-3391) , label(54973-3391)

Revised: 12/2021
 
Hyland's