NDC 54973-3391 Baby Oral Pain Relief Drops

Ferrosoferric Phosphate,tribasic Calcium Phosphate,oyster Shell Calcium Carbonate,crude,arnica Montana,arabica Coffee Bean And Matricaria Chamomilla

NDC Product Code 54973-3391

NDC Code: 54973-3391

Proprietary Name: Baby Oral Pain Relief Drops Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Ferrosoferric Phosphate,tribasic Calcium Phosphate,oyster Shell Calcium Carbonate,crude,arnica Montana,arabica Coffee Bean And Matricaria Chamomilla Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 54973 - Hyland's
    • 54973-3391 - Baby Oral Pain Relief Drops

NDC 54973-3391-1

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 29.6 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Baby Oral Pain Relief Drops with NDC 54973-3391 is a a human over the counter drug product labeled by Hyland's. The generic name of Baby Oral Pain Relief Drops is ferrosoferric phosphate,tribasic calcium phosphate,oyster shell calcium carbonate,crude,arnica montana,arabica coffee bean and matricaria chamomilla. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Hyland's

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Baby Oral Pain Relief Drops Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ARNICA MONTANA 30 [hp_X]/mL
  • OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X]/mL
  • TRIBASIC CALCIUM PHOSPHATE 12 [hp_X]/mL
  • FERROSOFERRIC PHOSPHATE 12 [hp_X]/mL
  • ARABICA COFFEE BEAN 6 [hp_X]/mL
  • MATRICARIA CHAMOMILLA 12 [hp_X]/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

* Please review the disclaimer below.

Baby Oral Pain Relief Drops Product Label Images

Baby Oral Pain Relief Drops Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Arnica Montana 30X HPUSCalcarea Carbonica 12X HPUSCalcarea Phosphorica 12X HPUSChamomilla 12X HPUSCoffea Cruda 6X HPUSFerrum Phosphoricum 12X HPUS“HPUS” indicates that the active ingredients are in the official HomeopathicPharmacopœia of the United States.

Purpose

Arnica Montana 30X HPUS...............................sore, sensitive or swelling gumsCalcarea Carbonica 12X HPUS..........................sore, sensitive or swelling gumsCalcarea Phosphorica 12X HPUS..................sensitive, swelling gums, oral painChamomilla 12X HPUS.....................................sore, sensitive or swelling gumsCoffea Cruda 6X HPUS..........................................................oral pain, irritabilityFerrum Phosphoricum 12X HPUS......................oral discomfort, swelling gums

Uses

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

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.

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 yearsof 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.

* Please review the disclaimer below.

Previous Code
54973-3383
Next Code
54973-3393