4KIDS COLD N MUCUS NIGHTTIME- onion, bryonia alba root, matricaria recutita, arabica coffee bean, euphrasia stricta, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, rumex crispus root, silicon dioxide, and sulfur liquid

4Kids Cold N Mucus Nighttime by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

• Active ingredients: Purpose
• Allium Cepa 6X HPUS: runny nose with mucus, hacking cough, sore throat
• Bryonia Alba 6X HPUS: stubborn mucus in throat,cough with yellowish mucus
• Chamomilla 3X HPUS: irritability, fussiness, occasional sleeplessness
• Coffea Cruda 3X HPUS: occasional sleeplessness, restlessness
• 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
• Hydrastis 6X HPUS: cough with mucus, dry, sore throat, occasional sleeplessness due to mucus in throat
• Natrum Muriaticum 6X HPUS: accumulation of mucus in throat, cough up mucus
• Nux Vomica 6X HPUS (0.0000016% Alkaloids, calculated): tired, difficulty falling asleep, frequent waking
• 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
• Sulphur 12X HPUS: cough with thick mucus, chest congestion, nasal congestion

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

Uses

Temporarily relieves the symptoms of the common cold in children especially at night including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion and occasional sleeplessness.

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 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 preprinted tamper band is broken or missing.

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

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 at bedtime and every 4 hours during the night or as necessary
• Children 6 years to under 12 years: 10 mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary
• Adults and children 12 years and over: 15 mL or 3 teaspoons at bedtime and every 4 hours during the night or as necessary

Inactive ingredients

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

Questions or comments?

(800) 624-9659

PURPOSE

Temporarily relieves the symptoms of the common cold in children especially at night including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion and occasional sleeplessness.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC: 54973-3250-1

HOMEOPATHIC

Natural

Relief

Ages

2-12

SINCE 1903

Hyland's ®

4Kids

Cold 'n
Mucus *

NIGHTTIME

Loosens mucus in
chest, throat and nose

Mucus & Congestion

Occasional Sleeplessness

Runny Nose

Cough

LESS THAN 0.2% ALCOHOL
SUGAR FREE
DYE FREE

SAFE &
EFFECTIVE

4 FL. OZ. (118 mL)

INGREDIENTS AND APPEARANCE

4KIDS COLD N MUCUS NIGHTTIME 
onion, bryonia alba root, matricaria recutita, arabica coffee bean, euphrasia stricta, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, rumex crispus root, silicon dioxide, and sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3250
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
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	3 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	3 [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
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	6 [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
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3250-1	1 in 1 CARTON	04/29/2016
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-3250-2	5 mL in 1 POUCH; Type 0: Not a Combination Product	11/11/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/29/2016

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3250) , pack(54973-3250)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		079424083	manufacture(54973-3250) , pack(54973-3250)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		117337220	pack(54973-3250)