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

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 4 Kids Nighttime Cold & Cough 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

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

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 YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

■ The inner packaged bottle is child-resistant.

■ Store at room temperature.

■ Do not refrigerate.

Inactive ingredients

Citric Acid, Glycerine, Glycyrrhiza Extract,Natural Grape Flavor Purified Water, Sodium Benzoate.

Questions or comments?

(800) 624-9659

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

Principal Display Panel - 4 FL OZ (118 mL) Bottle Carton

HOMEOPATHIC

NDC 54973-3377-1

2-12

YEARS

NEW

LOOK

4 KIDS

SINCE 1903

Hyland's

NIGHTTIME

Cold &

Cough*

Relieves congestion,

runny nose, sore throat,

sneezing, cough, post nasal drip

and occasional sleeplessness

NO ALCOHOL or PARABENS

NO SUGAR or DYES

NATURAL

RELIEF

NATURAL

GRAPE

FLAVOR

4 FL. OZ. (118 mL)

*SEE NOTE

ON SIDE PANEL

BELOW DRUG FACTS

carton

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 Product11/01/2018
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 (028570695)
Registrant - Standard Homeopathic Company (Hyland's) (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Standard Homeopathic Company008316655manufacture(54973-3377) , pack(54973-3377) , label(54973-3377)
Establishment
NameAddressID/FEIBusiness Operations
LGM Pharma Solutions, LLC117549198manufacture(54973-3377) , pack(54973-3377) , label(54973-3377)
Establishment
NameAddressID/FEIBusiness Operations
Applied Laboratories, Inc.876754375manufacture(54973-3377) , pack(54973-3377) , label(54973-3377)

Revised: 5/2021
 
Hyland's