DEFEND COLD AND MUCUS- bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone patens, rumex crispus root, and silicon dioxide liquid

Defend Cold and Mucus by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Bryonia 6X HPUS	stubborn mucus in throat, cough with yellowish mucus
Euphrasia Officinalis 6X HPUS	cough with mucus in chest
Hepar Sulph Calc 12X HPUS	cough up mucus, mucus rattle with cough, stubborn mucus in chest
Natrum Muriaticum 30X HPUS	accumulation of mucus in throat, cough up mucus
Phosphorus 30X HPUS	cough with expectoration of yellow mucus, chest congestion
Pulsatilla 6X HPUS	accumulation of mucus, discharge of thick, yellowish mucus, loose cough
Rumex Crispus 6X HPUS	runny nose, sneezing
Silicea 12X HPUS	nasal congestion

Uses

Temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and nasal congestion.

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
• Cough tends to recur or is accompanied by a 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.

Do not use this product for persistent or chronic cough such as occurs with asthma, smoking or emphysema or if cough is accompanied by excessive phlegm (mucus).

A persistent cough may be a sign of a serious condition.

Do not use if imprinted tamper band is broken or missing.

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

• Measure only with the dosing cup provided
• Do not use dosing cup with other products
• On dosing cup, mL = millimeter, tsp = teaspoon

• adults and children 12 years and over: 15 mL or 3 teaspoons up to 6 times per day (every 4 hours)
• children 6 years to under 12 years: 10 mL or 2 teaspoons up to 6 times per day (every 4 hours)
• children 2 years to under 6 years: 5 mL or 1 teaspoon up to 6 times per day (every 4 hours)

Inactive Ingredients

Citric Acid, Glycyrrhiza Extract, Purified Water, Sodium Benzoate, Vegetable Glycerine.

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC: 54973-3183-1
HOMEOPATHIC

NEW!

SINCE 1903
Hyland's®

DEFEND™

COLD+
MUCUS*

NON-DROWSY

Expectorant

Thins & Loosens Mucus in Chest, Throat and Nose

Natural, Safe & Effective Relief of:

Cough with Mucus

Nasal & Chest Congestion

Dye Free Sugar Free
Less than 0.1% Alcohol

4 FL. OZ. (118 mL)

INGREDIENTS AND APPEARANCE

DEFEND COLD AND MUCUS 
bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone patens, rumex crispus root, and silicon dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3183
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	6 [hp_X]  in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	30 [hp_X]  in 1 mL
PULSATILLA PATENS WHOLE (UNII: 4M1169RWJD) (PULSATILLA PATENS WHOLE - UNII:4M1169RWJD)	PULSATILLA PATENS WHOLE	6 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS ROOT	6 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3183-1	1 in 1 CARTON	07/01/2014
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/01/2014

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3183) , pack(54973-3183)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc		079424083	manufacture(54973-3183) , pack(54973-3183) , label(54973-3183)