4 Kids Cold And Cough Nighttime (Onion, Calcium Sulfide, Sodium Chloride, Anemone Pulsatilla, Arabica Coffee Bean, Matricaria Chamomilla, Sulfur, Phosphorus And Goldenseal) Liquid [Hyland's] -

4 KIDS COLD AND COUGH NIGHTTIME (ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL) LIQUID [HYLAND'S]
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NDC	54973-3375-1, 54973-3375-2, 54973-3375-3
Set ID	71e93027-33c9-6147-e053-2a95a90aaa09
Category	HUMAN OTC DRUG LABEL
Packager	Hyland's
Generic Name
Product Class
Product Number
Application Number

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Drug Facts

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 symptoms of common cold in children at night, including:

■ cough ■ runny nose ■ post nasal drip

■ sneezing ■ nasal or chest congestion

■ sore throat ■ occasional sleeplessness
Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache,
rash, nausea, or vomiting, consult a doctor promptly.

Ask a doctor before use if you have:  persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition.  cough that is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if:  symptoms persist for more than 7 days or worsen.  inflammation, fever or infection is
present or develops.  cough tends to recur or is accompanied by a fever, rash or persistent headache.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

Directions

 Use as directed.  Do not refrigerate.  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.

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.
OTHER SAFETY INFORMATION

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

Hyland's

NATURALS™

•Kids•

Cold &

Cough*

NIGHTTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES

Sleeplessness

Congestion

Runny Nose

Sore Throat

Cough

Post Nasal

Drip

2-12

YEARS

4 FL. OZ. (118 mL)

HOMEOPATHIC

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)

Registrant - Standard Homeopathic Company (Hyland's) (008316655)

Name	Address	ID/FEI	Business Operations
Establishment
Standard Homeopathic Company		080253323	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)

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Medic

4 KIDS COLD AND COUGH NIGHTTIME (ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL) LIQUID [HYLAND'S]

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