4Kids Cold n Cough Nighttime Grape Flavor

4Kids Cold n Cough Nighttime Grape Flavor

Drug Labeling and Warnings

Drug Details

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4KIDS COLD N COUGH NIGHTTIME GRAPE FLAVOR- onion, matricaria recutita, arabica coffee bean, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, and sulfur 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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4Kids Cold n Cough Nighttime Grape Flavor

Drug Facts

Drug Facts

Active ingredientsPurpose

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

Nux Vomica 6X HPUS

(0.0000016% Alkaloids, calculated)

frequent waking

Phosphorus 12X HPUS

hoarse/dry cough, nasal congestion, chest congestion

Pulsatilla 6X HPUS

moist cough, cold, nasal congestion

Sulphur 12X HPUS

chest congestion, nasal congestion, sneezing, runny nose

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

Uses

Temporarily relieves the symptoms of the common cold including cough, runny nose, sneezing, nasal and chest congestion, and 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 high fever (101°F)
  • Cough tends to recur or is accompanied by high fever, rash or persistent headache

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or a Poison Control Center immediately.

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 health care 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.

Do not use if imprinted tamper band is broken or missing.

Drug Facts (continued)

In case of emergency, 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.

Directions

  • Measure only with the dosing cup provided
  • Do not use dosing cup with other products
  • On dosing cup, mL = milliliter, tsp = teaspoon

Children 2 years to under 6 years5 mL or 1 teaspoon at bedtime and every 4 hours during the night or as necessary
Children 6 years to under 12 years10 mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary
Adults and children 12 years and over15 mL or 3 teaspoons at bedtime and every 4 hours during the night or as necessary

Inactive ingredients

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

Questions or comments?

(800) 624-9659

Temporarily relieves the symptoms of the common cold including cough, runny nose, sneezing, nasal and chest congestion, and sore throat with accompanying occasional sleeplessness.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC: 54973-3245-1
HOMEOPATHIC

Ages 2-12

SINCE 1903
Hyland's®

4Kids

Cold 'n
Cough*

NIGHTTIME

Natural Grape Flavor

Chest Congestion

Occasional Sleeplessness

Runny Nose

Sore Throat

Sneezing

Cough

Natural Grape Flavor

ALCOHOL FREE
SUGAR FREE
DYE FREE

SAFE &
EFFECTIVE

4 FL. OZ. (118 mL)

Carton

4KIDS COLD N COUGH NIGHTTIME GRAPE FLAVOR 
onion, matricaria recutita, arabica coffee bean, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, and sulfur liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54973-3245
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [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
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [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)  
GLYCERIN (UNII: PDC6A3C0OX)  
LICORICE (UNII: 61ZBX54883)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Natural Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54973-3245-11 in 1 CARTON04/18/2016
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC: 54973-3245-25 mL in 1 PACKET; Type 0: Not a Combination Product04/18/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/18/2016
Labeler - Hyland's (028570695)
Establishment
NameAddressID/FEIBusiness Operations
Standard Homeopathic Company008316655manufacture(54973-3245) , pack(54973-3245)
Establishment
NameAddressID/FEIBusiness Operations
Applied Laboratories, Inc.117337220manufacture(54973-3245) , pack(54973-3245)

Revised: 12/2017
 
Hyland's


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