4 Kids Cold 'n Mucus Nighttime

4 Kids Cold 'n Mucus Nighttime
SPL v6
SPL
SPL Set ID 6f7b2585-2f0e-5938-e053-2a91aa0aa9d1
Route
ORAL
Published
Effective Date 2018-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Onion (6 [hp_X]) Bryonia Alba Root (3 [hp_X]) Matricaria Chamomilla (12 [hp_X]) Euphrasia Stricta (30 [hp_X]) Goldenseal Chloride Ion Sulfur Arabica Coffee Bean Calcium Sulfide Phosphorus Anemone Pulsatilla Rumex Crispus Root Silicon Dioxide
Inactive Ingredients
Citric Acid Monohydrate Glycerin Water Glycyrrhiza Glabra Sodium Benzoate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-06-27 Until 2021-12-15

Description

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 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 that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.


Medication Information

Description

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 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 that 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.

Section 42229-5

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.

Section 50565-1

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.

Section 50569-3

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.
Section 50570-1

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

Section 53414-9

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Section 55105-1

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

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 that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

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 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

Primary Principal Display 4 Fl. Oz. (118 Ml) Bottle Carton

NDC 54973-3372-2

HOMEOPATHIC

Ages

2-12

NATURAL

RELIEF

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

4 FL. OZ. (118 mL)


Structured Label Content

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.

Section 42229-5 (42229-5)

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.

Section 50565-1 (50565-1)

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.

Section 50569-3 (50569-3)

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.
Section 50570-1 (50570-1)

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

Section 53414-9 (53414-9)

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Section 55105-1 (55105-1)

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

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 that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

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 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 (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

(800) 624-9659

Primary Principal Display 4 Fl. Oz. (118 Ml) Bottle Carton (PRIMARY PRINCIPAL DISPLAY - 4 FL. OZ. (118 mL) BOTTLE CARTON)

NDC 54973-3372-2

HOMEOPATHIC

Ages

2-12

NATURAL

RELIEF

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

4 FL. OZ. (118 mL)


Advanced Ingredient Data


Raw Label Data

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