DEFEND™ Cough Syrup

DEFEND™ Cough Syrup

Drug Labeling and Warnings

Drug Details

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DEFEND COUGH- bryonia alba root, causticum, drosera rotundifolia, ipecac, phosphorus, rumex crispus root, and spongia officinalis skeleton, roasted syrup 
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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DEFEND™ Cough Syrup

Drug Facts

Active ingredients	Purpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Bryonia 6X HPUS	dry cough
Causticum 6X HPUS	hoarse cough
Drosera Rotundifolia 6X HPUS	dry cough
Ipecacuanha 6X HPUS	gagging cough
Phosphorus 12X HPUS	tickling cough
Rumex Crispus 6X HPUS	moist cough
Spongia Tosta 6X HPUS	barking cough

Uses

Temporarily relieves the symptoms of dry, hoarse, gagging, tickling, moist, or barking cough due to colds.

Warnings

As with any drug, ask a doctor before use if pregnant or nursing. Consult a physician if:

• Cough is persistent or chronic
• Cough is accompanied by excessive mucus
• Cough persists for more than 7 days or worsens
• Cough tends to recur or is accompanied by a high fever (101°F), rash or 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.

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, tsp = teaspoon, mL = milliliter

• adults and children 12 years and over: 10 mL or 2 teaspoons up to 4 times per day (every 6 hours)
• children 2 years to under 12 years: 5 mL or 1 teaspoon up to 4 times per day (every 6 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: 54973-3185-1
HOMEOPATHIC

SINCE 1903
Hyland's®

DEFEND™

COUGH*

NON-DROWSY

Natural, Safe & Effective Relief of:

Dry Cough
Tickling Cough
Moist Cough

Dye Free Sugar Free
Less than 0.1% Alcohol

4 FL. OZ. (118 mL)

DEFEND COUGH 
bryonia alba root, causticum, drosera rotundifolia, ipecac, phosphorus, rumex crispus root, and spongia officinalis skeleton, roasted syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3185
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
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	6 [hp_X]  in 1 mL
DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ)	DROSERA ROTUNDIFOLIA	6 [hp_X]  in 1 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS ROOT	6 [hp_X]  in 1 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID)	SPONGIA OFFICINALIS SKELETON, ROASTED	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LICORICE (UNII: 61ZBX54883)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3185-1	1 in 1 CARTON
1		118 mL in 1 BOTTLE, PLASTIC

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(54973-3185) , PACK(54973-3185)

Revised: 4/2014

Document Id: f5c64dcf-82cf-481e-a791-4133a677fe50

Set id: 491dc1e0-3bdd-475a-965d-61f7b2a799aa

Version: 1

Effective Time: 20140417

 

Hyland's