Cold - Sinus
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2022-03-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:17:10
Label at a glance#
ProductCold - Sinus
Active ingredientSINUSITISINUM, INFLUENZA A VIRUS, AMERICAN GINSENG, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, EUPHRASIA STRICTA, GAULTHERIA PROCUMBENS TOP, GELSEMIUM SEMPERVIRENS ROOT, CALCIUM SULFIDE, HISTAMINE DIHYDROCHLORIDE, GOLDENSEAL, POTASSIUM DICHROMATE, MERCURY, PHOSPHORUS, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SCHOENOCAULON OFFICINALE SEED, SAGE, LOBARIA PULMONARIA, VERBASCUM THAPSUS, ECHINACEA, UNSPECIFIED, INFLUENZA B VIRUS
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a doctor before use.
WARNINGS SECTION
WARNGINGS: 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 doctror. If pregnant or breast-feeding, ask a doctor before use.
QUESTIONS SECTION
newtonlabs.net - Questions? 800 448-7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
INACTIVE INGREDIENT SECTION
USP Purified water, USP Gluten-free, non-GMO, organic cane alcohol 20%.
OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Hydrastis 6x, Aralia quin. 15x, Arsenicum alb. 15x, Bryonia 15x, Euphrasia 15x, Gaultheria 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Merc. viv. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Sabadilla 15x, Salvia 15x, Sticta 15x, Verbascum 15x, Sinusitisinum 16x, Influenzinum 30x.
INDICATIONS & USAGE SECTION
Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.
DOSAGE & ADMINISTRATION SECTION
Ages 12 and up, take 6 drops by mouth (ages 4 to 11, give 3 drops) as needed or as directed by a health professional. Under age 4, consult a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.
PACKAGE LABEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 63f39a63-5cd1-4016-bd86-2bbb0f6c3139 | Product name | 3 | 20240506 |
| e5a77e9c-c528-733a-173d-914a234c024b | Product name | 5 | 20240506 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-2406-0 | Cold - Sinus | 15 mL in 1 BOTTLE, GLASS | LIQUID | 15 | 4 | |
| 55714-2406-1 | Cold - Sinus | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | 4 | |
| 55714-2406-2 | Cold - Sinus | 50 mL in 1 BOTTLE, GLASS | LIQUID | 50 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-2406 | COLD - SINUS (INFLUENZA A VIRUS, INFLUENZA B VIRUS, ARALIA QUINQUEFOLIA, ARSENICUM ALB., BRYONIA, EUPHRASIA, GAULTHERIA PROCUBENS, GELSEMIUM, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABADILLA, SALVIA, STICTA, VERBASCUM, ECHINACEA) LIQUID [NEWTON LABORATORIES, INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20220318_7a40e3b3-baa7-3ce8-e053-2991aa0a4d07.zip |
Products#
Every source-derived product name is available through these pages.
- Cold - Sinus
- Influenza A Virus, Influenza B Virus, Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procubens, Gelsemium, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Kali bic., Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabadilla, Salvia, Sticta, Verbascum, Echinacea
- SINUSITISINUM
- ALCOHOL
- INFLUENZA A VIRUS
- AMERICAN GINSENG
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- BRYONIA ALBA ROOT
- EUPHRASIA STRICTA
- GAULTHERIA PROCUMBENS TOP
- GELSEMIUM SEMPERVIRENS ROOT
- CALCIUM SULFIDE
- HISTAMINE DIHYDROCHLORIDE
- HISTAMINE
- GOLDENSEAL
- POTASSIUM DICHROMATE
- DICHROMATE ION
- MERCURY
- PHOSPHORUS
- PULSATILLA VULGARIS
- TOXICODENDRON PUBESCENS LEAF
- SCHOENOCAULON OFFICINALE SEED
- SAGE
- LOBARIA PULMONARIA
- VERBASCUM THAPSUS
- ECHINACEA, UNSPECIFIED
- INFLUENZA B VIRUS
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2406 | 55714-2406-1, 55714-2406-2, 55714-2406-0 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Cold - Sinus | INFLUENZA A VIRUS, INFLUENZA B VIRUS, ARALIA QUINQUEFOLIA, ARSENICUM ALB., BRYONIA, EUPHRASIA, GAULTHERIA PROCUBENS, GELSEMIUM, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABADILLA, SALVIA, STICTA, VERBASCUM, ECHINACEA | Newton Laboratories, Inc. | 7a40e3b3-baa7-3ce8-e053-2991aa0a4d07 | 2022-03-17 | Warnings | 55714-2406-2 55714-2406-0 55714-2406-1 55714-2406 55714240602 55714240601 55714240600 da713283-6759-5474-e053-2a95a90a70d4 7a40e3b3-baa7-3ce8-e053-2991aa0a4d07 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.