The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Amoebasode (NDC 57520-0219). 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 - keep out of reach of children, indications & usage, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ACTIVE INGREDIENTS: Triticum aestivum 1X, Cajuputum 1X, Baptisia tinctoria 3X, Capsicum annuum 3X, Columbo 3X, Fragaria vesca 3X, Quassia amara 3X, Senna 3X, Absinthium 6X, Hepar bovinum 8X, 10X, 12X, 24X, Spleen 8X, 10X, 12X, 24X, Glandula suprarenalis bovinum 8X, 12X, 24X, 30X, Cinchona officinalis 12X, Lycopodium clavatum 12X, Amoeba 30X, 60X, 200X, 6C, 30C, Giardia 30X, 60X, 200X, 6C, 30C.
INDICATIONS: For temporary relief of symptoms of diarrhea, mucous in stools, and intestinal bloating.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
If pregnant or breast-feeding, ask a health professional before use.
Do not use if tamper evident seal is broken or missing.
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.
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.
INDICATIONS: For temporary relief of symptoms of diarrhea, mucous in stools, and intestinal bloating.
Distributed by:
SYNERGY FORMULAS, INC.
251 West Road
Campobello, SC 29322
Synergy Formulas
AMOEBASODE
HOMEOPATHIC
2 FL OZ (60 ml)
Amoebasode (Mm1)
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