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

4 Kids Oral Pain Relief Nighttime by

Drug Labeling and Warnings

4 Kids Oral Pain Relief Nighttime 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, oral pain

• Ferrum Phosphoricum 12X HPUS:

  tooth pain, oral discomfort, swelling of gums

• Magnesia Phosphoricum 12X HPUS:

  tooth pain, occasional sleeplessness

• Silicea 12X HPUS:

  tooth pain at night, occcasional sleeplessness

"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 disconfort with occasional sleeplessness.

WARNINGS

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

Do not use more than directed if your child has 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 persist or worsens

Keep this and all medication 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 an emergency

contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emeregency 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 Nighttime 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

PRICIPAL DISPLAY PANEL - 125 TABLET CARTON

New!

NDC: 54973-3325-1

HOMEOPATHIC

Natural

Relief

Ages

2-12

SINCE 1903

Hyland's

4Kids

Oral Pain Relief

NIGHTTIME

Toothache

Sensitive Teeth

Swelling Gums

Oral Disconfort

Occasional Sleeplessness

ACTUAL SIZE 65 MG

125 QUICK-DISSOLVING TABLETS

SAFE & EFFECTIVE

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3325
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
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	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
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7)	FERRUM PHOSPHORICUM	12 [hp_X]  in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [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

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	white (Of 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: 54973-3325-1	1 in 1 CARTON	08/18/2017
1		125 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-3325-3	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
Standard Homeopathic Company		008316655	manufacture(54973-3325) , pack(54973-3325) , label(54973-3325)