RESPIRASODE- bryonia, dulcamara, kali carb, sanguinaria, belladonna, bromium, candida alb, candida parap, conium, lycopodium, pulsatilla, secale, silicea, sticta, sulphur, ustilago maidis liquid

Respirasode by

Drug Labeling and Warnings

Respirasode by is a Homeopathic medication manufactured, distributed, or labeled by Natural Creations, Inc, OHM Pharma, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.**

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.

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

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.

PRINCIPAL DISPLAY PANEL

NDC: 43406-0089-1

Respirasode

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

INGREDIENTS AND APPEARANCE

RESPIRASODE 
bryonia, dulcamara, kali carb, sanguinaria, belladonna, bromium, candida alb, candida parap, conium, lycopodium, pulsatilla, secale, silicea, sticta, sulphur, ustilago maidis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43406-0089
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	30 [hp_C]  in 1 mL
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N)	SOLANUM DULCAMARA TOP	30 [hp_C]  in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	30 [hp_C]  in 1 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	30 [hp_C]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	30 [hp_C]  in 1 mL
BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G)	BROMINE	30 [hp_C]  in 1 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC)	CANDIDA ALBICANS	30 [hp_C]  in 1 mL
CANDIDA PARAPSILOSIS (UNII: 0KZ676D44N) (CANDIDA PARAPSILOSIS - UNII:0KZ676D44N)	CANDIDA PARAPSILOSIS	30 [hp_C]  in 1 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	30 [hp_C]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_C]  in 1 mL
PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	PULSATILLA VULGARIS WHOLE	30 [hp_C]  in 1 mL
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N)	CLAVICEPS PURPUREA SCLEROTIUM	30 [hp_C]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	30 [hp_C]  in 1 mL
LOBARIA PULMONARIA (UNII: D1YM0P5Z2T) (LOBARIA PULMONARIA - UNII:D1YM0P5Z2T)	LOBARIA PULMONARIA	30 [hp_C]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 [hp_C]  in 1 mL
USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG)	USTILAGO MAYDIS	30 [hp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43406-0089-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	05/22/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/22/2012

Labeler - Natural Creations, Inc (018022074)

Establishment
Name	Address	ID/FEI	Business Operations
OHM Pharma, Inc		030572478	manufacture(43406-0089)