Otc - Active Ingredient
Active ingredients:
Arsenicum album 12X, Calcarea carbonica 30X, Kali bichromicum 12X, Mercurius solubilis 30X, Mercurius sulphuratus ruber 12X, Pulsatilla 12X, Sepia 12X, Sulphur 30X, 1 g each in 10 g.
Dr. Reckeweg R49 Rhinopulsan
FDA Label NDC 53346-1349
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmazeutische Fabrik Dr. Reckeweg & Co for the product Dr. Reckeweg R49 Rhinopulsan (NDC 53346-1349). 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 - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Relieves symptoms associated with sinusitis
Indications & Usage
Uses
For the temporary relief of minor symptoms associated with sinusitis such as:
- Sinus headache
- Nasal congestion
- Sinus pressure and pain
- Runny nose
- Sneezing
Warnings
Warnings
Otc - Ask Doctor
Ask a doctor before use
- in children younger than 12 years.
Otc - When Using
When using this product
- in rare cases, hypersalivation may occur after use, in which case the use of the product should be discontinued
- in very rare cases, skin reactions may occur after use, in which case the product should be discontinued.
Otc - Stop Use
Stop use and ask a doctor if
- cold persists for more than 7 days
- fever persists for more than 3 days
- symptoms worsen or if new symptoms occur.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health care professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
Adults and children ≥ 12 years 5-10 drops 1-3 times daily, acute cases 4-6 times daily in a little water or undiluted or as recommended.
Not recommended for children under 12 years of age except under the advice of a health care professional.
Other Safety Information
Other information
Tamper resistant: do not use if safety ring at base of cap is broken.
Retain outer carton for full product instructions.
Inactive Ingredient
Inactive ingredients
Ethanol, purified water.
Otc - Questions
Package Label.Principal Display Panel
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Dr. Reckeweg R49 Rhinopulsan
Homeopathic preparation for the temporary relief of minor symptoms associated with sinusitis such as:
- Sinus headache
- Nasal congestion
- Sinus pressure and pain
- Runny nose
- Sneezing
Manufactured by:
Dr. Reckeweg Co. GmbH
D-64625 Bensheim
Germany
1.68 fl oz
(50 ml)
* Please review the disclaimer below.
