DEFEND COLD AND COUGH NIGHT- onion, coffee bean, chamomile, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, and sulfur liquid

Drug Details [pdf]

Drug Facts

Active ingredients	Purposes
Allium Cepa 6X HPUS	watery runny nose, cold, hacking cough
Coffea Cruda 6X HPUS	occasional sleeplessness
Chamomilla 6X HPUS	Sensitive, irritable, fussy, occasional sleeplessness
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
Nux Vomica 6X HPUS	tired, difficulty falling asleep, frequent waking
Phosphorus 12X HPUS	hoarse/dry cough, nasal congestion, chest congestion
Pulsatilla 6X HPUS	moist cough, cold, nasal congestion
Sulphur 12X HPUS	Chest congestion, nasal congestion, sneezing, runny nose

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

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

Uses

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

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 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)
Inactive ingredients

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

Directions

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

adults and children 12 years and over	15 mL or 3 teaspoons at bedtime and every 4 hours during the night or as necessary
children 6 years to under 12 years	10 mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary
children 2 years to under 6 years	5 mL or 1 teaspoon at bedtime and every 4 hours during the night or as necessary

Questions or comments?

(800) 624-9659
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC: 54973-3123-1

HOMEOPATHIC

Since 1903
Hyland's®

DEFEND™

COLD +
COUGH*

NIGHT

Natural,Safe & Effective Relief of:

Occasional Sleeplessness

Sore Throat

Congestion

Sneezing

Cough

Dye Free Sugar Free

Less than 0.1% Alcohol

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

DEFEND COLD AND COUGH NIGHT
onion, coffee bean, chamomile, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, and sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3123
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	6 [hp_X] in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	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
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X] in 1 mL
COFFEE BEAN (UNII: JFH385Y744) (COFFEE BEAN - UNII:JFH385Y744)	COFFEE BEAN	6 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 54973-3123-1	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/17/2011	12/31/2017
2	NDC: 54973-3123-4	1 in 1 CARTON	06/17/2011
2		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

Labeler - Hyland's (028570695)

Name	Address	ID/FEI	Business Operations
Establishment
Standard Homeopathic Company		008316655	manufacture(54973-3123)

Name	Address	ID/FEI	Business Operations
Establishment
NEXGEN PHARMA, INC		079424083	manufacture(54973-3123)

Name	Address	ID/FEI	Business Operations
Establishment
Lifetech Resources, LLC		622559110	manufacture(54973-3123)