4 KIDS COMPLETE COLD AND MUCUS- bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide liquid

4 Kids Complete Cold and Mucus by

Drug Labeling and Warnings

4 Kids Complete Cold and Mucus by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc., Applied Laboratories, Inc., LGM Pharma Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

• Active ingredients: Purpose
• Bryonia 6X HPUS: stubborn mucus in throat, cough with yellowish mucus
• Euphrasia Officinalis 6X HPUS: cough with mucus in chest
• Hepar Sulph Calc 12X HPUS: cough up mucus, mucus rattle with cough, stubborn mucus in chest
• Natrum Muriaticum 30X HPUS: accumulation of mucus in throat, cough up mucus
• Phosphorus 30X HPUS: cough with expectoration of yellow mucus, chest congestion
• Pulsatilla 6X HPUS: accumulation of mucus, discharge of thick yellowish mucus, loose cough
• Rumex Crispus 6X HPUS: runny nose, sneezing
• Silicea 12X HPUS: nasal congestion

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

Uses

Temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and nasal congestion.

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
• infalmation, fever or infection develops.
• symptoms are accompanied by a high fever (over 101°F).
• Cough tends to recur or is accompanied by a 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 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 accompanied by high fever, headache,nausea and vomitting me ay be serious. Consult a doctor promptly.

Do not use if imprinted tamper-evident bottle 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.

Drug Facts (continued)

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

PURPOSE

Temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and nasal congestion.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC: 54973-3179-1

HOMEOPATHIC

Ages
2-12

Natural
Relief

SINCE 1903
Hyland's®
4 Kids

Cold 'n
Mucus *

DAYTIME

Loosens mucus in
chest, throat and nose

Mucus & Congestion

Runny Nose

Cough

ALCOHOL FREE
SUGAR FREE
DYE FREE

4 FL. OZ. (118 mL)

INGREDIENTS AND APPEARANCE

4 KIDS COMPLETE COLD AND MUCUS 
bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3179
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
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	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	30 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	30 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [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: 54973-3179-1	1 in 1 CARTON	07/01/2014
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-3179-2	1 in 1 CARTON	10/17/2014
2		19.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 54973-3179-4	10 in 1 CARTON	07/01/2014
3		5 mL in 1 POUCH; Type 0: Not a Combination Product

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(54973-3179) , pack(54973-3179)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		079424083	manufacture(54973-3179) , pack(54973-3179)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		117337220	pack(54973-3179)