Cold 4768-Disc
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2026-03-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:51:04
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Formulated for coughs associated with allergies, post-nasal drip, croup and colds.
DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 drops or pellets by mouth (ages 4 to 11, give 3 drops or pellets) one to four times daily or as directed by a health professional. Under age 4, consult a health professional. Under age 2, crush/dissolve pellets in purified water.
OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Lappa 6x, Antimon. tart. 15x, Arsenicum alb. 15x, Bryonia 15x, Chelidonium maj. 15x, Cinchona 15x, Drosera 15x, Eucalyptus 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Kali carb. 15x, Kali iod. 15x, Myrrha 15x, Nat. sulphuricum 15x, Nux vom. 15x, Phos. 15x, Pulsatilla 15x, Rumex crisp. 15x, Sambucus nig. 15x, Spongia 15x, Tussilago far. 15x, Verbascum 15x, Influenzinum 30x.
OTC - PURPOSE SECTION
Formulated for coughs associated with allergies, post-nasal drip, croup and colds.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.
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
Keep out of reach of children
PACKAGE LABEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 95250459-30e4-45c1-b08a-993044f49109 | Product name | 2 | 20250805 |
| 63f39a63-5cd1-4016-bd86-2bbb0f6c3139 | Product name | 3 | 20240506 |
| e5a77e9c-c528-733a-173d-914a234c024b | Product name | 5 | 20240506 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 9badc7be-250a-44ab-aa36-926af3f02679 | Product name | 1 | 20210527 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 26acd337-b838-40ac-bcbc-05c3b81c8712 | Product name | 1 | 20170323 |
Products#
Every source-derived product name is available through these pages.
- Cold-Cough
- Echinacea, Lappa, Antimon. tart., Arsenicum alb., Bryonia, Chelidonium maj., Cinchona, Drosera, Eucalyptus, Histaminum hydrochloricum, Hydrastis, Kali bic., Kali carb., Kali iod., Myrrha, Nat. sulphuricum, Nux vom., Phos., Pulsatilla, Rumex crisp., Sambucus nig., Spongia, Tussilago far., Verbascum, Influenzinum.
- SUCROSE
- INFLUENZA A VIRUS
- ANTIMONY POTASSIUM TARTRATE
- ANTIMONY CATION (3+)
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- BRYONIA ALBA ROOT
- CHELIDONIUM MAJUS
- CINCHONA OFFICINALIS BARK
- DROSERA ANGLICA
- EUCALYPTUS GUM
- HISTAMINE DIHYDROCHLORIDE
- HISTAMINE
- GOLDENSEAL
- POTASSIUM DICHROMATE
- DICHROMATE ION
- POTASSIUM CARBONATE
- CARBONATE ION
- POTASSIUM IODIDE
- IODIDE ION
- MYRRH
- SODIUM SULFATE
- SODIUM SULFATE ANHYDROUS
- STRYCHNOS NUX-VOMICA SEED
- PHOSPHORUS
- ANEMONE PULSATILLA
- RUMEX CRISPUS ROOT
- SAMBUCUS NIGRA FLOWERING TOP
- SPONGIA OFFICINALIS SKELETON, ROASTED
- TUSSILAGO FARFARA
- VERBASCUM THAPSUS
- ECHINACEA, UNSPECIFIED
- ARCTIUM LAPPA ROOT
- INFLUENZA B VIRUS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4768 | 55714-4768-1 |
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 |
|---|---|---|---|---|---|---|
| 497909c0-634e-00f6-e063-6294a90a0b89 | 995bd7d9-2aef-3792-e053-2a95a90a746d | 2026-03-02 | Warnings | 497909c0-634e-00f6-e063-6294a90a0b89 995bd7d9-2aef-3792-e053-2a95a90a746d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
