DEFEND COLD AND COUGH- onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid

Defend Cold and Cough by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active ingredients:

  Purpose

• Allium Cepa 6X HPUS:

  watery, runny nose, cold, hacking cough

• Hepar Sulph Calc 12X HPUS:

  cold, sneezing

• Hydrastis 6X HPUS:

  rattling/tickling cough, sinus congestion, dry/raw/sore throat

• Natrum Muriaticum 6X HPUS:

  dry cough, sore throat

• Phosphorus 12X HPUS:

  hoarse/dry cough, nasal congestion, chest congestion

• Pulsatilla 6X HPUS:

  moist cough, cold, nasal congestion

• Sulphur 12X HPUS:

  nasal congestion, chest congestion, sneezing, runny nose

“HPUS” indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

Temporarily relieves the symptoms of the common cold including nasal and chest congestion, runny nose, cough, sore throat and sneezing.

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 occurs with 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 imprinted tamper band is broken or missing.

There have been no reports of interactions between this product and ibuprofen or acetaminophen.

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.

Drug Facts (Continued)

Directions

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

• 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

PURPOSE

Temporarily relieves the symptoms of the common cold including nasal and chest congestion, runny nose, cough, sore throat and sneezing.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC: 54973-3124-1

HOMEOPATHIC

SINCE 1903
Hyland's®

DEFEND™

COLD+
COUGH*

NON-DROWSY

Safe & Effective Relief of:

• Nasal Congestion
• Sore Throat
• Sneezing
• Cough

Dye Free Sugar Free

Less Than 0.1% Alcohol

4 FL. OZ. (118 mL)

INGREDIENTS AND APPEARANCE

DEFEND COLD AND COUGH 
onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3124
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	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	6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [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: 54973-3124-1	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/17/2011	12/31/2017
2	NDC: 54973-3124-3	19.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/17/2011	12/31/2017
3	NDC: 54973-3124-4	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/17/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/17/2011

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3124) , pack(54973-3124)

Establishment
Name	Address	ID/FEI	Business Operations
NEXGEN PHARMA, INC		079424083	manufacture(54973-3124) , pack(54973-3124)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources, LLC		622559110	manufacture(54973-3124) , pack(54973-3124)