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

Defend Severe Cold and Flu by

Drug Labeling and Warnings

Defend Severe Cold and Flu by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's, Standard Homeopathic Company, LGM Pharma Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients 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

Uses

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.

Warnings

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.

Directions

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).

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

NDC: 54973-3156-2

HOMEOPATHIC

SINCE 1903

Hyland's®

DEFEND ™

SEVERE

COLD + FLU

Natural,Safe & Effective Relief of:

Runny Nose, Nasal Congestion

Body Aches & Headache

Sore Throat

Fatigue

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)