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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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4 Kids Cold'n Cough Nighttime

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

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

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

carton

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3375
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3375-11 in 1 CARTON07/01/2018
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:54973-3375-25 mL in 1 PACKET; Type 0: Not a Combination Product07/01/201812/15/2021
3NDC:54973-3375-31 in 1 CARTON07/01/2018
3148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/01/2018
Labeler - Hyland's (028570695)
Registrant - Standard Homeopathic Company (Hyland's) (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Standard Homeopathic Company080253323manufacture(54973-3375) , pack(54973-3375) , label(54973-3375)
Establishment
NameAddressID/FEIBusiness Operations
Applied Laboratories, Inc.876754375manufacture(54973-3375) , pack(54973-3375) , label(54973-3375)

Revised: 12/2021
Document Id: d339557a-43ca-651e-e053-2a95a90af60e
Set id: 71e93027-33c9-6147-e053-2a95a90aaa09
Version: 8
Effective Time: 20211215
 
Hyland's