4KIDS COLD N MUCUS NIGHTTIME- onion, bryonia alba root, matricaria recutita, arabica coffee bean, euphrasia stricta, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, rumex crispus root, silicon dioxide, 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 Mucus Nighttime

Drug Facts

Active ingredients Purpose
Allium Cepa 6X HPUS runny nose with mucus, hacking cough, sore throat
Bryonia Alba 6X HPUS stubborn mucus in throat,cough with yellowish mucus
Chamomilla 3X HPUS irritability, fussiness, occasional sleeplessness
Coffea Cruda 3X HPUS occasional sleeplessness, restlessness
Euphrasia Officinalis 6X HPUS cough with mucus in chest
Hepar Sulph Calc 12X HPUS cough up mucus, mucus rattle with cough, stubborn mucus in chest
Hydrastis 6X HPUS cough with mucus, dry, sore throat, occasional sleeplessness due to mucus in throat
Natrum Muriaticum 6X HPUS accumulation of mucus in throat, cough up mucus
Nux Vomica 6X HPUS
(0.0000016% Alkaloids, calculated)
tired, difficulty falling asleep, frequent waking
Phosphorus 30X HPUS cough with expectoration of yellow mucus, chest congestion
Pulsatilla 6X HPUS accumulation of mucus, discharge of thick yellowish mucus, loose cough
Rumex Crispus 6X HPUS runny nose, sneezing
Silicea 12X HPUS nasal congestion
Sulphur 12X HPUS cough with thick mucus, chest congestion, nasal congestion

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

Uses

Temporarily relieves the symptoms of the common cold in children especially at night including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion and 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 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 preprinted 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

Children 2 years to under 6 years 5 mL or 1 teaspoon at bedtime and every 4 hours during the night or as necessary
Children 6 years to under 12 years 10 mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary
Adults and children 12 years and over 15 mL or 3 teaspoons at bedtime and every 4 hours during the night or as necessary

Inactive ingredients

Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

Questions or comments?

(800) 624-9659

Temporarily relieves the symptoms of the common cold in children especially at night including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion and occasional sleeplessness.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC 54973-3250-1

HOMEOPATHIC

Natural

Relief

Ages

2-12

SINCE 1903

Hyland's ®

4Kids

Cold 'n
Mucus *

NIGHTTIME

Loosens mucus in
chest, throat and nose

Mucus & Congestion

Occasional Sleeplessness

Runny Nose

Cough

LESS THAN 0.2% ALCOHOL
SUGAR FREE
DYE FREE

SAFE &
EFFECTIVE

4 FL. OZ. (118 mL)

carton

4KIDS COLD N MUCUS NIGHTTIME
onion, bryonia alba root, matricaria recutita, arabica coffee bean, euphrasia stricta, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, rumex crispus root, silicon dioxide, and sulfur liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3250
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 3 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 3 [hp_X]  in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT 6 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
LICORICE (UNII: 61ZBX54883)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54973-3250-1 1 in 1 CARTON 04/29/2016
1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2 NDC:54973-3250-2 5 mL in 1 POUCH; Type 0: Not a Combination Product 11/11/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 04/29/2016
Labeler - Hyland's (028570695)
Establishment
Name Address ID/FEI Business Operations
Standard Homeopathic Company 008316655 manufacture(54973-3250) , pack(54973-3250)
Establishment
Name Address ID/FEI Business Operations
Nexgen Pharma, Inc. 079424083 manufacture(54973-3250) , pack(54973-3250)
Establishment
Name Address ID/FEI Business Operations
Applied Laboratories, Inc. 117337220 pack(54973-3250)

Revised: 12/2017
Document Id: 6026f2cc-e881-9e89-e053-2991aa0a449d
Set id: a27c429b-afdb-4fef-b91c-3fbd35557d6f
Version: 3
Effective Time: 20171212
Hyland's