The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Stomaplex (NDC 57520-0326). 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 otc - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - questions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ACTIVE INGREDIENTS: Carduus marianus 3X, Gentiana lutea 3X, Sambucus nigra 3X, Senna 3X, Stomach 8X, Arsenicum album 12X, Atropinum sulphuricum 12X, Carbo vegetabilis 12X, Lycopodium clavatum 12X, Nux vomica 12X, Phosphorus 12X.
INDICATIONS: For temporary relief of aching in the stomach, nausea, flatulence, fullness in the abdomen, and indigestion.
WARNINGS: If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is broken or missing.
Store in a cool, dry place.
DIRECTIONS: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
INACTIVE INGREDIENTS: Demineralized water, 25% Ethanol
Distributed By:
BioActive Nutritional
Melbourne, FL 32935
For Nutritional Information Write:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
BioActive Homeopathic
STOMAPLEX
1 FL OZ (30 ML)
Stomaplex (Mm1)
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