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

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.

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.

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

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

Carton Art

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3316
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
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [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
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM12 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
ACACIA (UNII: 5C5403N26O)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3316-11 in 1 CARTON08/18/2017
1125 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:54973-3316-36 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 (028570695)
Establishment
NameAddressID/FEIBusiness Operations
Standar Homeopathic Company008316655manufacture(54973-3316) , pack(54973-3316) , label(54973-3316)

Revised: 12/2021
Document Id: d34bf6fe-6938-67c8-e053-2995a90a342b
Set id: 58ece525-b626-fa51-e053-2991aa0a35ef
Version: 4
Effective Time: 20211216
 
Hyland's