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

COUGH BABY by

Drug Labeling and Warnings

COUGH BABY by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Uses

Temporarily relieves the symptoms of simple, dry, tight or tickling coughs due to colds in children.

Warnings

Do not use

• for persistent or chronic cough such as occurs with asthma, smoking or emphysema
• 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.

Stop use and ask a doctor if

• symptoms persist for more than 48 hours or worsen
• 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.

Directions

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

• children under 6 months of age: consult a licensed health care professional before using this product
• children 6 months to under 1 year of age: 2.5 mL or ½ teaspoon up to 4 times daily (every 6 hours)
• children 1 to 3 years of age: 5 mL or 1 teaspoon up to 6 times daily (every 4 hours)

Other information

• do not use if imprinted tamper band is broken or missing
• Hyland's may be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659

Inactive ingredients

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

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC: 54973-3154-2
HOMEOPATHIC

Ages
6 months+

SINCE 1903
Hyland's®
Baby

Natural
Relief

Cough
Syrup

RELIEF OF COUGHS
DUE TO COLDS*

• No Alcohol, Artificial Flavors,
  Dyes or Parabens

4 FL. OZ. (118 mL)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3154
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	6 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA 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
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [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
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS ROOT	6 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3154-2	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/17/2012
2	NDC: 54973-3154-1	19.81 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/17/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/17/2012

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3154) , pack(54973-3154)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc		079424083	manufacture(54973-3154) , pack(54973-3154)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources, LLC		622559110	manufacture(54973-3154) , pack(54973-3154)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		876754375	manufacture(54973-3154) , pack(54973-3154)