Indications & Usage Section
Fever, Headache, Ear and Throat Pain, Swollen Neck Glands.
Belladonna
FDA Label NDC 55714-6091
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Belladonna (NDC 55714-6091). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications & usage section, dosage & administration section, otc - active ingredient section, otc - purpose section, inactive ingredient section, questions section, warnings section, otc - pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration Section
Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.
Otc - Active Ingredient Section
Belladonna 15x, 10x, 200c, 30c.
Otc - Purpose Section
Fever, Headache, Ear and Throat Pain, Swollen Neck Glands.
Inactive Ingredient Section
Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.
Questions Section
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256
Warnings Section
Warning: 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 Image (S091 L01)
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