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
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 that 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 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 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.

Drug Facts (continued)

Do not use if imprinted tamper-evident bottle band is broken or missing.

The inner packaged bottle is child-resistant. 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

PRIMARY PRINCIPAL DISPLAY - 4 FL. OZ. (118 mL) BOTTLE CARTON

NDC 54973-3372-2

HOMEOPATHIC

Ages

2-12

NATURAL

RELIEF

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

4 FL. OZ. (118 mL)

carton1

carton2

4 KIDS COLD AND MUCUS NIGHTTIME
euphrasia stricta,silicon dioxide, rumex crispus root, anemone pulsatilla, goldenseal, sodium chloride, phosphorus, onion, bryonia alba root, matricaria chamomilla, arabica coffee bean, calcium sulfide and sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-3372
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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 CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	3 [hp_X] in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6 [hp_X] in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X] in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	3 [hp_X] in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [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

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
SODIUM BENZOATE (UNII: OJ245FE5EU)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54973-3372-2	1 in 1 CARTON	06/27/2018
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:54973-3372-1	1 in 1 CARTON	08/01/2018
2		148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:54973-3372-3	5 mL in 1 PACKET; Type 0: Not a Combination Product	06/27/2018	12/15/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/27/2018

Labeler - Hyland's Inc. (008316655)

Name	Address	ID/FEI	Business Operations
Establishment
LGM Pharma Solutions, LLC		117549198	pack(54973-3372) , label(54973-3372) , manufacture(54973-3372)

Name	Address	ID/FEI	Business Operations
Establishment
Applied Laboratories, Inc.		117337220	manufacture(54973-3372) , pack(54973-3372) , label(54973-3372)

4 Kids Cold 'n Mucus Nighttime