The following Structured Product Label (SPL) was submitted to the FDA by Pharmazeutische Fabrik Dr. Reckeweg & Co for the product (NDC 53346-1306). 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, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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Active ingredients
Aconitum napellus 4X, Baptisia tinctoria 4X, Bryonia 4X, Camphora 3X, Causticum 6X, Eucalyptus globulus 3X, Eupatorium perfoliatum 3X, Ferrum phosphoricum 8X, Gelsemium sempervirens 6X, Sabadilla 6X, 1 g each in 10 g.
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Purpose
Relieves symptoms associated with colds and flu
Uses
For the temporary relief of minor symptoms associated with colds and flu:
* Sneezing
* Running nose
* Coughing
* Minor sore throat pain
* Fever
Warnings
Ask a doctor before use
* in children younger than 2 years
Stop use and ask a doctor if
* symptoms persist for more than 7 days (5 days for children)
* fever persists for more than 3 days
* symptoms worsen or if new symptoms occur
* redness or swelling is present, because these could be signs of a serious condition
* sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting.
If pregnant or breastfeeding, ask a health care professional before use.
Keep out of reach of children.
Directions
Adults: 10-15 drops; children (6-12 years of age): 5-8 drops;
children (2-6 years of age): 2-5 drops, every 15 minutes to 2 hours in a little water or undiluted or as recommended.
Not recommended for children under 2 years of age except under the advice of a health care professional.
Other information
* Tamper resistant: Do not use if safety ring at base of cap is broken.
* Retain outer carton for full product instructions.
Inactive ingredients
Ethanol, purified water.
Questions?
Call 1-800-361-7872 or email [email protected]
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