Indications and uses
Temporarily relieves the symptoms of gum or tooth sensitivity, swelling of gums, tooth and oral pain and discomfort.
4 Kids Oral Pain Relief
- Manufacturer
- Hyland's Inc.
- Effective date
- 2022-11-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 02:18:37
Label at a glance#
Product4 Kids Oral Pain Relief
Active ingredientOYSTER SHELL CALCIUM CARBONATE, CRUDE, ARABICA COFFEE BEAN, ARNICA MONTANA, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA, FERRUM PHOSPHORICUM
Label structure8 sections
Dosage and administration
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 Tablet...
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
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 SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
OTC - DO NOT USE SECTION
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 SECTION
Acacia Gum, Lactose.
Questions or comments?
(800) 624-9659
OTC - PURPOSE SECTION
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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| efd58dcf-540a-4531-8766-e713129ca6f2 | Product name | 1 | 20250307 |
| 4b7700e3-6e0e-45e5-9d22-6f754d61386e | Product name | 2 | 20250304 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54973-3316 | 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 INC.] | 5 | Legacy NDC | 20221124_58ece525-b626-fa51-e053-2991aa0a35ef.zip |
Products#
Every source-derived product name is available through these pages.
- 4 Kids Oral Pain Relief
- Oyster Shell Calcium Carbonate, Crude, Arabica Coffee Bean, Arnica Montana, Tribasic Calcium Phosphate, Ferrum Phosphoricum and Matricaria Chamomilla
- LACTOSE MONOHYDRATE
- ANHYDROUS LACTOSE
- ACACIA
- OYSTER SHELL CALCIUM CARBONATE, CRUDE
- ARABICA COFFEE BEAN
- ARNICA MONTANA
- TRIBASIC CALCIUM PHOSPHATE
- PHOSPHATE ION
- MATRICARIA CHAMOMILLA
- FERRUM PHOSPHORICUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54973-3316 | 54973-3316-1, 54973-3316-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| ACACIA | 5C5403N26O | IACT |
| OYSTER SHELL CALCIUM CARBONATE, CRUDE | 2E32821G6I | ACTIB |
| ARABICA COFFEE BEAN | 3SW678MX72 | ACTIB |
| ARNICA MONTANA | O80TY208ZW | ACTIB |
| TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | ACTIB |
| MATRICARIA CHAMOMILLA | G0R4UBI2ZZ | ACTIB |
| FERRUM PHOSPHORICUM | 91GQH8I5F7 | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 41b263e2-8b5b-c913-e063-6294a90a82bc | 58ece525-b626-fa51-e053-2991aa0a35ef | 2025-10-21 | Warnings | 58ece525-b626-fa51-e053-2991aa0a35ef |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.