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

4 Kids Oral Pain Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

• Active ingredients:

  Purpose

• Arnica Montana 30X HPUS:

  tooth pain, sensitive or swelling gums

• Calcarea Carbonica 12X HPUS:

  tooth pain, sensitive gums or teeth

• Calcarea Phosphorica 12X HPUS:

  sensitive gums or teeth, oral pain

• Chamomilla 12X HPUS:

  tooth pain, sensitive gums or teeth

• Coffea Cruda 6X HPUS:

  tooth pain, irritability

• Ferrum Phosphoricum 12X HPUS:

  tooth pain, oral discomfort, swelling of gums

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

Pharmacopœia of the United States.

Uses

Temporarily relieves the symptoms of gum or tooth sensitivity, swelling of gums, tooth and oral pain and discomfort.

WARNINGS

As with any drug, ask doctor before use if pregnant or breast-feeding.

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 band is broken or missing.

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 2 years to under 6 years of age: dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

Children 6 years to under 12 years of age: dissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

Adults and Children 12 years and over: dissolve 4 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

Hyland’s Oral Pain Relief Tablets are very soft and will dissolve instantly in the mouth.

INACTIVE INGREDIENT

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

PURPOSE

Oral Pain Relief

PRINCIPAL DISPLAY PANEL - 125 TABLET CARTON

New!

NDC: 54973-3316-1

HOMEOPATHIC

Ages

2-12

Natural

Relief

SINCE 1903

Hyland's®

4 Kids

Oral Pain Relief

Toothache

Sensitive Teeth

Swelling Gums

Oral Disconfort

ACTUAL SIZE 65 MG

125 QUICK-DISSOLVING

TABLETS

SAFE &

EFFECTIVE

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3316
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
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
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
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7)	FERRUM PHOSPHORICUM	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: 54973-3316-1	1 in 1 CARTON	08/18/2017
1		125 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-3316-3	6 g in 1 PACKET; Type 0: Not a Combination Product	08/18/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/18/2017

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standar Homeopathic Company		008316655	manufacture(54973-3316) , pack(54973-3316) , label(54973-3316)