4 KIDS COLD AND COUGH NIGHTTIME NATURAL GRAPE FLAVOR- onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean liquid 
Hyland's Inc.

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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Hyland's Naturals Kids Cold & Cough Nighttime Natural Grape Flavor

Relieves congestion, runny nose, sore throat, sneezing, cough, post nasal drip and occasional sleeplessness

Drug Facts

Active ingredients

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

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,Natural Grape Flavor Purified Water, Sodium Benzoate.

Questions?

www.hylands.com or care@hylands.com

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

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

Uses

■ Helps temporarily relieve symptoms of common cold in children at night, including:

■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ sore throat

■ nasal or chest congestion ■ occasional sleeplessness

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

NATURAL

GRAPE FLAVOR

4 FL. OZ. (118 mL)

HOMEOPATHIC

Carton

label

NDC 54973-3377-3 5 FL. OZ. (148 mL)

2

label

4 KIDS COLD AND COUGH NIGHTTIME NATURAL GRAPE FLAVOR 
onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3377
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3377-11 in 1 CARTON11/01/2018
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:54973-3377-25 mL in 1 PACKET; Type 0: Not a Combination Product11/01/201812/15/2021
3NDC:54973-3377-31 in 1 CARTON11/01/2018
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 homeopathic11/01/2018
Labeler - Hyland's Inc. (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Hyland's Inc.008316655manufacture(54973-3377) , pack(54973-3377) , label(54973-3377)

Revised: 6/2023
Document Id: feb923fe-6d36-e75a-e053-6294a90a24c7
Set id: 7923e59a-f62c-44df-e053-2991aa0afc1e
Version: 10
Effective Time: 20230622
 
Hyland's Inc.