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

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.

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Hyland's Defend Cold + Cough

Drug Facts

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

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)

carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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:54973-3124-1	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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/17/2011	12/28/2021

Labeler - Hyland's (028570695)

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

Name	Address	ID/FEI	Business Operations
Establishment
LGM Pharma Solutions, LLC		117549198	manufacture(54973-3124) , pack(54973-3124) , label(54973-3124)

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

Revised: 12/2021

Document Id: d43d3150-df97-81b1-e053-2a95a90a168b

Set id: 89912adc-af3d-4f40-bb43-bb403501189c

Version: 6

Effective Time: 20211228

Hyland's