Sulphur
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2020-12-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:01:06
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Unhealthy hair & skin; Burning with itching; Styes; Burning in eyes; Diarrhea; Vertigo.
DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.
OTC - ACTIVE INGREDIENT SECTION
Sulphur 15x, 10x, 200c, 30c.
OTC - PURPOSE SECTION
Unhealthy hair & skin; Burning with itching; Styes; Burning in eyes; Diarrhea; Vertigo.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose free) pellets.
QUESTIONS SECTION
newtonlabs.net - Questions? 1.800.448.7256
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-7516-1 | 2022-12-21 | C162847 | 48780-1 | d6a99b39-e832-a426-e053-dadaa90af4c2 | Sulphur 7516P |
| 55714-7516-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e832-a426-e053-dadaa90af4c2 | Sulphur 7516P |
Products#
Every source-derived product name is available through these pages.
- Sulphur
- SUCROSE
- SULFUR
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-7516 | 55714-7516-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCROSE | C151H8M554 | IACT |
| SULFUR | 70FD1KFU70 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| f05c1ba0-1c3b-0f10-e053-2995a90ab9c8 | 93a53c31-17f0-3d19-d0e0-7d2cae3d432d | 2022-12-21 | Warnings | 93a53c31-17f0-3d19-d0e0-7d2cae3d432d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
