Active Ingredients:
Drosera (Rotundifolia) 4X, Coccus Cacti 5X, Spongia Tosta 5X, Belladonna 6X, Cuprum Aceticum 12X, Kali Carbonicum 12X, Mentha Piperita 12X, Phosphorus 12X.
Cough Syrup Formula Liquid
FDA Label NDC 43857-0548
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bioactive Nutritional, Inc. for the product Cough Syrup Formula (NDC 43857-0548). 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 active ingredients:, indications:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications:
For temporary relief of irritable, dry, tickling cough associated with flu, spasmodic cough worse at night & cough with expectorations.
For temporary relief of irritable, dry, tickling cough associated with flu, spasmodic cough worse at night & cough with expectorations.
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 cool, dry place.
Keep Out Of Reach Of Children:
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions:
SHAKE WELL.
1 teaspoon every 2-3 hours, children under 12, 1/2 adult dose.
Consult a physician for use in children under 12 years of age.
Inactive Ingredients:
Demineralized Water, Dextrose, Essential Oil Blend [Anise (Seed), Eucalyptus (Leaf)], Ethanol, 10% Herbal Extracts [Chamomile (Flower), Echinacea Angustifolia (Aerial Parts), High Mallow (Flower), Iceland Moss (Whole Plant), Mullein (Leaf), Plantain (Leaf), Red Clover (Flower), Stinging Nettle (Leaf), Thyme (Leaf)], Honey, Natural Cherry Flavor, Natural Mixed Berry Flavor.
Questions:
Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com
Package Label Display:
BioActive Homeopathic
COUGH SYRUP FORMULA
4 FL OZ (120 ml)
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