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 
Hyland's Inc.

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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4 Kids Oral Pain Relief Nighttime

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.

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.

Acacia Gum, Lactose

Questions or comments?

(800) 624-9659.

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

Carton

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3325
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 g
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]  in 1 g
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 g
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM12 [hp_X]  in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]  in 1 g
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE12 [hp_X]  in 1 g
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA12 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
Colorwhite (Of White) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3325-11 in 1 CARTON08/18/2017
1125 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:54973-3325-36 g in 1 PACKET; Type 0: Not a Combination Product08/18/201712/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/18/2017
Labeler - Hyland's Inc. (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Hyland's Inc.008316655manufacture(54973-3325) , pack(54973-3325) , label(54973-3325)

Revised: 11/2022
Document Id: ee180cdd-90b8-b803-e053-2a95a90aec8c
Set id: 58b2bd93-e980-ed15-e053-2991aa0aca03
Version: 5
Effective Time: 20221122
 
Hyland's Inc.