FDA Label for Respirasode
View Indications, Usage & Precautions
Respirasode Product Label
The following document was submitted to the FDA by the labeler of this product Natural Creations, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Bryonia 6C, 12C, 30C, Dulcamara 6C, 12C, 30C, Kali Carb 6C, 12C, 30C, Sanguinaria 6C, 12C, 30C, Belladonna 30C, Bromium 30C, Candida Alb 30C, Candida Parap 30C, Conium 30C, Lycopodium 30C, Pulsatilla 30C, Secale 30C, Silicea 30C, Sticta 30C, Sulphur 30C, Ustilago Maidis 30C
Indications & Usage
USES: Temporarily relieves cough, stuffy and dry nose, and/or symptoms related to cold.**
Otc - Purpose
USES: Temporarily relieves cough, stuffy and dry nose, and/or symptoms related to cold.**
Dosage & Administration
DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
Warnings
WARNINGS:
- Consult a physician for use in children under 12 years of age.
- IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
- KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
- A persistent cough may be a sign of a serious condition. If cough persists more than 1 week, tends to recur, or is accompanied by fever, rash, or headache, consult a doctor.
- Do not use if TAMPER EVIDENT seal is broken or missing.
Inactive Ingredient
INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water
Otc - Questions
QUESTIONS & COMMENTS?
Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600
References
*The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Package Label.Principal Display Panel
NDC:43406-0089-1
Respirasode
HOMEOPATHIC
1 fl oz (30mL) / 20% Alcohol
* Please review the disclaimer below.