Indications and uses
Formuated for associated symptoms such as inconsolable crying, painful and swollen gums and sleeplessness.
Teething-Colic
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2025-11-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:37:25
Label at a glance#
ProductTeething-Colic
Active ingredientVALERIAN, COLLINSONIA CANADENSIS ROOT, APIS MELLIFERA, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, SODIUM BORATE, BRYONIA ALBA ROOT, OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA, CHELIDONIUM MAJUS, ARABICA COFFEE BEAN, WOOD CREOSOTE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, STRYCHNOS NUX-VOMICA SEED, PODOPHYLLUM, RHEUM OFFICINALE ROOT, SCUTELLARIA LATERIFLORA WHOLE, SILICON DIOXIDE, TURPENTINE OIL, GINGER, CITRULLUS COLOCYNTHIS FRUIT PULP, ACONITUM NAPELLUS
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS AND USAGE SECTION
Formuated for associated symptoms such as inconsolable crying, painful and swollen gums and sleeplessness.
DOSAGE & ADMINISTRATION SECTION
Directions: Children, ages 0 to 11, give 3 drops by mouth (ages 12 and up, give 6 drops) as needed or a directed by a health professional. Sensitive person begin with 1 drop and gradually increase to full dose.
OTC - ACTIVE INGREDIENT SECTION
Equal parts of Chamomilla 6x, Valeriana officinalis 6x, Aconitum napellus 15x, Apis mellifica 15x, Baptisia tinctoria 15x, Belladonna 15x, Borax 15x, Bryonia 15x, Calcarea carbonica 15x, Calcarea phosphorica 15x, Chamomilla 15x, Chelidonium majus 15x, Coffea cruda 15x, Collinsonia canadensis 15x, Colocynthis 15x, Kreosotum 15x, Magnesia phosphorica 15x, Nux vomica 15x, Podophyllum peltatum 15x, Rheum 15x, Scutellaria lateriflora 15x, Silicea 15x, Terebinthina 15x, Zingiber officinale 15x.
OTC - PURPOSE SECTION
Formuated for associated symptoms such as inconsolable crying, painful and swollen gums and sleeplessness.
INACTIVE INGREDIENT SECTION
USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%
QUESTIONS SECTION
newtonlabs.net – Questions? 800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
WARNINGS SECTION
WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a doctor before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
WARNINGS: Keep out of reach of children.
PACKAGE LABEL
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-1530-1 | Teething-Colic | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | 3 |
Products#
Every source-derived product name is available through these pages.
- Teething-Colic
- Chamomilla, Valeriana officinalis, Aconitum napellus, Apis mellifica, Baptisia tinctoria, Belladonna, Borax, Bryonia, Calcarea carbonica, Calcarea phosphorica, Chamomilla, Chelidonium majus, Coffea cruda, Collinsonia canadensis, Colocynthis, Kreosotum, Magnesia phosphorica, Nux vomica, Podophyllum peltatum, Rheum, Scutellaria lateriflora, Silicea, Terebinthina, Zingiber officinale
- VALERIAN
- COLLINSONIA CANADENSIS ROOT
- APIS MELLIFERA
- BAPTISIA TINCTORIA ROOT
- ATROPA BELLADONNA
- SODIUM BORATE
- BORATE ION
- BRYONIA ALBA ROOT
- OYSTER SHELL CALCIUM CARBONATE, CRUDE
- TRIBASIC CALCIUM PHOSPHATE
- PHOSPHATE ION
- MATRICARIA CHAMOMILLA
- CHELIDONIUM MAJUS
- ARABICA COFFEE BEAN
- WATER
- WOOD CREOSOTE
- MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
- MAGNESIUM CATION
- STRYCHNOS NUX-VOMICA SEED
- PODOPHYLLUM
- RHEUM OFFICINALE ROOT
- ALCOHOL
- SCUTELLARIA LATERIFLORA WHOLE
- SILICON DIOXIDE
- TURPENTINE OIL
- GINGER
- CITRULLUS COLOCYNTHIS FRUIT PULP
- ACONITUM NAPELLUS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-1530 | 55714-1530-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2025-01-27 | full-release | 2026-06-01 02:31:34 |
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 |
|---|---|---|---|---|---|---|
| Teething-Colic | CHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALE | Newton Laboratories, Inc. | 9db30229-3031-ff10-e053-2995a90aff75 | 2025-11-06 | Warnings | 55714-1530-1 55714-1530 55714153001 42f36188-97a7-5c4b-e063-6394a90ae52d 9db30229-3031-ff10-e053-2995a90aff75 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.