Label: DEFEND SEVERE COLD AND FLU- aconitum napellus root, cairina moschata heart/liver autolysate, bryonia alba root, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide powder
- NDC Code(s): 54973-3156-1, 54973-3156-2
- Packager: Hyland's
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Updated June 9, 2017
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Each packet contains 160 mg of:
Purpose "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Aconitum Napellus 6X HPUS Sore throat, cough Anas Barbariae Hepatis et Cordis Extractum 200C HPUS Early onset flu, including fever, chills and body aches Bryonia 6X HPUS Headache, fatigue, fever Eupatorium Perfoliatum 6X HPUS Fever with chills, body aches, headache Euphrasia Officinalis 6X HPUS Nasal congestion, runny nose, cough Gelsemium Sempervirens 6X HPUS Hoarse throat, fatigue, fever Kali Iodatum 6X HPUS Headache, sore throat
temporarily relieves the symptoms of severe cold and flu including the early onset of flu, runny nose and nasal congestion, sore, hoarse throat, cough, headache and body aches, fatigue, fever and chills.Close
As with any drug, ask a doctor before use if pregnant or nursing. Consult a physician if:
- Symptoms persist for more than 7 days or worsen
- Inflammation, fever or infection develops
- Symptoms are accompanied by high fever (101°F)
- Cough tends to recur or is accompanied by high fever, rash or persistent headache
Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately.
Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional.
A persistent cough may be a sign of a serious condition.
Sore throat warning
Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.
Do not use if packet is torn or damaged.
In case of emergency, contact a medical professional or poison control center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
Sip while hot • Consume entire drink within 10-15 minutes • If using a microwave, heat the water first and then add the contents of the packet while stirring
adults and children 12 years and over dissolve one packet in 8 oz of hot water up to 6 times a day (every 4 hours) or as directed by a licensed health care professional children 6 years to under 12 years dissolve half a packet in 4 oz of warm water up to 6 times a day (every 4 hours) or as directed by a licensed health care professional children 2 years to under 6 years consult a doctor
- Inactive Ingredients
Citric Acid USP, Fructose, Honey Powder, Lactose N.F., Natural Color, Natural Flavors, Silicon Dioxide (absorbs moisture).Close
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 6 Packet Carton
COLD + FLU
Natural,Safe & Effective Relief of:
Runny Nose, Nasal Congestion
Body Aches & Headache
Natural Lemon & Honey Flavor
Dye Free • No Artificial Flavors or Sweeteners
6 PACKETS | (0.56 OZ EACH) NET WT. 3.36 OZ
- INGREDIENTS AND APPEARANCE
DEFEND SEVERE COLD AND FLU
aconitum napellus root, cairina moschata heart/liver autolysate, bryonia alba root, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3156 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS ROOT (UNII: KPD2N7348X) (ACONITUM NAPELLUS ROOT - UNII:KPD2N7348X) ACONITUM NAPELLUS ROOT 6 [hp_X] CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE (UNII: RN2HC612GY) (CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE - UNII:RN2HC612GY) CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C] BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X] EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X] GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 6 [hp_X] Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FRUCTOSE (UNII: 6YSS42VSEV) HONEY (UNII: Y9H1V576FH) LACTOSE (UNII: J2B2A4N98G) GREEN TEA LEAF (UNII: W2ZU1RY8B0) LEMON (UNII: 24RS0A988O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color Score Shape Size Flavor LEMON (Natural Honey Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3156-1 8 in 1 CARTON; Type 0: Not a Combination Product 04/01/2013 2 NDC:54973-3156-2 6 in 1 CARTON; Type 0: Not a Combination Product 04/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/01/2013 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3156) , pack(54973-3156) Establishment Name Address ID/FEI Business Operations Nexgen Pharma,Inc. 079424083 manufacture(54973-3156) , pack(54973-3156)