Drug Labeling and Warnings

Drug Details

k">

4 KIDS COLD N COUGH DAY AND NIGHT VALUE PACK- 4 kids cold n cough day and night value pack 
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.

----------

DAYTIME Drug Facts

Active ingredients Purpose

Allium Cepa 6X HPUS watery, runny nose, cold, hacking cough, painful throat

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, nasal congestion

Sulphur 12X HPUS chest congestion, nasal congestion, sneezing, runny nose

"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses Temporarily relieves the symptoms of the

common cold including nasal and chest congestion,

runny nose, sore throat, sneezing and cough.

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 highfever, 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 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 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.

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

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

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 up to 6 times per day (every 4 hours)
Children 6 years to under 12 years10 mL or 2 teaspoons up to 6 times per day (every 4 hours)
Adults and children up to 12 years and over15 mL or 3 teaspoons up to 6 times per day (every 4 hours)

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

NIGHTTIME

Drug Facts

Active ingredientsPurpose
Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, painful throat
Chamomilla 6X HPUSsensitive, irritable, fussy, nocturnal occasional sleeplessness
Coffea Cruda 6X HPUSoccasional sleeplessness, restlessness
Hepar Sulph Calc 12X HPUScold, sneezing
Hydrastis 6X HPUSrattling/tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUSdry cough, sore throat
Nux Vomica 6X HPUStired, difficulty falling asleep, (0.0000016% Alkaloids, calculated) frequent waking
Phosphorus 12X HPUShoarse/dry cough, nasal congestion, chest congestion
Pulsatilla 6X HPUS

moist cough, cold, nasal congestion

Sulphur 12X HPUSchest congestion,nasal congestion, sneezing, runny nose

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

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

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 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 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.

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

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

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.

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

(800) 624-9659

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

Natural Grape Flavor!

Natural Relief

NDC: 54973-3326-1

HOMEOPATHIC

Ages
2-12

Hyland's

4 Kids

Cold 'n Cough

Day & Night Value Pack

DAYTIME

Nasal Congestion

Runny Nose

Sore Throat

Sneezing

Cough

Natural Grape Flavor

ALCOHOL FREE
SUGAR FREE
DYE FREE

4 FL. OZ. (118 mL) Daytime

NIGHTTIME

Chest Congestion

Sleeplessness

Runny Nose

Sore Throat

Sneezing

Cough

Natural Grape Flavor

ALCOHOL FREE
SUGAR FREE
DYE FREE

4 FL. OZ. (118 mL) Nighttime

8 FL. OZ. (236 mL) TOTAL

16

4 KIDS COLD N COUGH DAY AND NIGHT VALUE PACK 
4 kids cold n cough day and night value pack kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54973-3326
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54973-3326-11 in 1 CARTON; Type 0: Not a Combination Product05/19/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 118 mL  in 236 
Part 21 BOTTLE, PLASTIC 118 mL  in 236 
Part 1 of 2
4 KIDS COLD N COUGH GRAPE FLAVOR 
onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid
Product Information
Item Code (Source)NDC: 54973-3243
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
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
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
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
LICORICE (UNII: 61ZBX54883)  
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: 54973-3243-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/10/2016
Part 2 of 2
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
Item 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
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [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
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LICORICE (UNII: 61ZBX54883)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
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: 54973-3245-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/18/2016
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/19/2017
Labeler - Hyland's (028570695)
Establishment
NameAddressID/FEIBusiness Operations
Standard Homeopathic Company008316655manufacture(54973-3326) , pack(54973-3326)
Establishment
NameAddressID/FEIBusiness Operations
Applied Laboratories, Inc.876754375manufacture(54973-3326) , pack(54973-3326)

Revised: 5/2017
 
Hyland's


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.