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#

ProductCold-Cough
Active ingredientINFLUENZA A VIRUS, ANTIMONY POTASSIUM TARTRATE, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS BARK, DROSERA ANGLICA, EUCALYPTUS GUM, HISTAMINE DIHYDROCHLORIDE, GOLDENSEAL, POTASSIUM DICHROMATE, POTASSIUM CARBONATE, POTASSIUM IODIDE, MYRRH, SODIUM SULFATE, 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
Label structure10 sections

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

OTC - 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-476855714-4768-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 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
497909c0-634e-00f6-e063-6294a90a0b89995bd7d9-2aef-3792-e053-2a95a90a746d2026-03-02WarningsExact identifier
spl id: 497909c0-634e-00f6-e063-6294a90a0b89
spl set id: 995bd7d9-2aef-3792-e053-2a95a90a746d

Reported adverse events (FAERS/openFDA)#

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