Comfort for Teething

Manufacturer
Vitality Works, Inc.
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:36:05

Label at a glance#

ProductComfort for Teething
Active ingredientMAGNESIUM PHOSPHATE, MONOBASIC, UNSPECIFIED, CHAMOMILE, ARNICA MONTANA, TRIBASIC CALCIUM PHOSPHATE, WOOD CREOSOTE, RHEUM OFFICINALE ROOT
Label structure9 sections

Dosage and administration

Do not use if printed neck seal is broken or missing use only as directed. For infants 4 months and older: give 4 drops under the tongue every 30 minutes for 4 doses. Then reduce to once every 4 hours or as recommended by a doctor.

Label contents#

Full prescribing information#

Directions for Use:

DOSAGE & ADMINISTRATION SECTION

Do not use if printed neck seal is broken or missing use only as directed. For infants 4 months and older: give 4 drops under the tongue every 30 minutes for 4 doses. Then reduce to once every 4 hours or as recommended by a doctor.

Ingredients, Active:

OTC - ACTIVE INGREDIENT SECTION

Chamomilla (Chamomile) 3X, Arnica montana (Arnica) 6X, Calcarea phosphorica (Calcium phosphate)6x, Kreosotum (Creosote) 6X, Magensia phosphorica (Magnesium phosphate) 6X, Rheum (Rhubarb) 6X.

Inactive ingredients

INACTIVE INGREDIENT SECTION

USP Purified water, Vegetable glycerine

Warnings:

WARNINGS SECTION

Do not use for more than 7 days unless directed by a physician. Stop use and ask a doctor if

  • symptoms do not improve in 7 days
  • swelling, rash, or fever develops
  • irritiation, pain or redness persists or worsens

If pregnant or nursing, ask a doctor before use

Indications:

OTC - PURPOSE SECTION

For the temporary relief of teething pain, soreness and inflammation of gums, restlessness and irritability related to teething.

Comments or Questions

OTC - QUESTIONS SECTION

Health for Kids Shelbourne Falls, MA 01370 USA

1-800-255-4463

www.herbsforkids.com

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, contact a medical professional or contact a poison control center immediately

INDICATIONS & USAGE SECTION

For the temporary relief of teething pain, soreness and inflammation of gums, restlessness and irritability related to teething

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

comfort for teething label.jpg

LabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130701619727837GTIN-13: 0701619727837
EAN-13: 0701619727837
GTIN-12: 701619727837
UPC-A: 701619727837
GTIN storage (14 digits): 00701619727837
Comfort for teething label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-115-01Comfort for Teething30 mL in 1 BOTTLE, DROPPERLIQUID308

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64616-11564616-115-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Comfort for TeethingCOMFORT FOR TEETHINGVitality Works, Inc.21b44c37-4fc8-14b4-e054-00144ff8d46c2025-12-17WarningsExact identifier
ndc (package): 64616-115-01
ndc (product): 64616-115
ndc11 (package): 64616011501
spl id: 462f6324-888c-e31c-e063-6394a90ad915
spl set id: 21b44c37-4fc8-14b4-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.