COLD N COUGH 4 KIDS- onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid

Cold and Cough 4 Kids by

Drug Labeling and Warnings

Cold and Cough 4 Kids by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc., Applied Laboratories, 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.
Allium Cepa 6X HPUS	watery/runny nose, cold, hacking cough, painful throat
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	chest congestion, nasal congestion, sneezing, runny nose

Uses

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

Warnings

As with any drug, ask a doctor before use if pregnant or breast-feeding. 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 asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed medical 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.

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, mL = milliliter, tsp = teaspoon

• Children 2 years to under 6 years: 5 mL or 1 teaspoon 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)
• Adults and children 12 years and over: 15 mL or 3 teaspoons up to 6 times per day (every 4 hours)

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: 54973-3075-1
HOMEOPATHIC

Ages
2-12

Natural
Relief

SINCE 1903
Hyland's®
4 kids

Cold 'n
Cough*

Nasal Congestion

Runny Nose

Sore Throat

Sneezing

Cough

ALCOHOL FREE
SUGAR FREE
DYE FREE

4 FL. OZ. (118 mL)

SAFE &
EFFECTIVE

INGREDIENTS AND APPEARANCE

COLD N COUGH 4 KIDS 
onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3075
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) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	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: 54973-3075-1	1 in 1 CARTON	08/01/2008
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-3075-2	1 in 1 CARTON	08/01/2008
2		19.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		08/01/2008

Labeler - HYLAND'S, INC. (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	MANUFACTURE(54973-3075)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources		622559110	MANUFACTURE(54973-3075) , PACK(54973-3075)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		079424083	MANUFACTURE(54973-3075) , PACK(54973-3075)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		876754375	MANUFACTURE(54973-3075) , PACK(54973-3075)