4 KIDS COLD AND COUGH NIGHTTIME- onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal liquid

Drug Details [pdf]

Active ingredients	Purpose
Allium Cepa 6X HPUS	watery/runny nose, cold, hacking cough, painful throat
Chamomilla 6X HPUS	sensitive, irritable, fussy, nocturnal occasional sleeplessness
Coffea Cruda 6X HPUS	occasional sleeplessness, restlessness
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, post nasal drip
Sulphur 12X HPUS	chest congestion, nasal congestion, sneezing, runny nose

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses
- Temporarily relieves the symptoms of the common cold, including:
- cough
- runny nose
- post nasal drip
- sneezing
- nasal or chest congestion
- sore throat with accompanying 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.

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.

In case of emergency or accidental overdose, 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

Shake well before using.
Measure only with the dosing cup provided.
Do not use dosing cup with other products.
On dosing cup, mL = milliliter.

Children 2 years

to under 6 years

5 mL at bedtime and every

4 hours during the night

until relieved

Children 6 years

to under 12 years

10 mL at bedtime and every

4 hours during the night

until relieved

Adults and

children 12 years

and over

15 mL at bedtime and every

4 hours during the night

until relieved

Other information

Do not use if imprinted "SEALED FOR YOURPROTECTION" tamper-evident bottle cap bandis broken or missing.
The inner packaged bottle is child-resistant.
Store at room temperature.
Do not refrigerate.

Inactive ingredients

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

Questions or comments?

(800) 624-9659

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
PRIMARY PRINCIPAL DISPLAY - 118 mL BOTTLE CARTON

NDC: 54973-3375-1

HOMEOPATHIC

Ages

2-12

NATURAL

RELIEF

SINCE 1903

Hyland's

4 Kids

Cold'n

Cough*

NIGHTTIME

Congestion

Occasional Sleeplessness

Runny Nose

Sneezing

Cough

+ also relieves

Post Nasal Drip

ALCOHOL FREE

SUGAR FREE

DYE FREE

4 FL. OZ. (118 mL)

*SEE NOTE ON SIDE PANEL BELOW DRUG FACTS

INGREDIENTS AND APPEARANCE

4 KIDS COLD AND COUGH NIGHTTIME
onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3375
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
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	6 [hp_X] in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	6 [hp_X] in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	6 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X] in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	6 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X] in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 54973-3375-1	1 in 1 CARTON	07/01/2018
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-3375-2	5 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2018
3	NDC: 54973-3375-3	1 in 1 CARTON	07/01/2018
3		148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/01/2018

Labeler - Hyland's (028570695)

Name	Address	ID/FEI	Business Operations
Establishment
Nexgen Pharma, Inc.		079424083	manufacture(54973-3375) , pack(54973-3375) , label(54973-3375)

Name	Address	ID/FEI	Business Operations
Establishment
Applied Laboratories, Inc.		876754375	manufacture(54973-3375) , pack(54973-3375) , label(54973-3375)