FDA Label for 4 Kids Cold And Mucus
View Indications, Usage & Precautions
4 Kids Cold And Mucus Product Label
The following document was submitted to the FDA by the labeler of this product Hyland's Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Bryonia Alba 6X HPUS
Euphrasia Officinalis 6X HPUS
Hepar Sulph Calc 12X HPUS
Natrum Muriaticum 30X HPUS
Phosphorus 30X HPUS
Pulsatilla 6X HPUS
Rumex Crispus 6X HPUS
Silicea 12X HPUS
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Allium Cepa 6X HPUS
Bryonia Alba 6X HPUS
Chamomilla 3X HPUS
Coffea Cruda 3X HPUS
Euphrasia Officinalis 6X HPUS
Hepar Sulph Calc 12X HPUS
Hydrastis 6X HPUS
Natrum Muriaticum 6X HPUS
Phosphorus 30X HPUS
Pulsatilla 6X HPUS
Rumex Crispus 6X HPUS
Silicea 12X HPUS
Sulphur 12X HPUS
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Otc - Purpose
Bryonia Alba 6X HPUS...stubborn mucus in throat, cough with yellowish mucus
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
Natrum Muriaticum 30X 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
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
Uses
Temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and nasal congestion.
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.
Otc - Pregnancy Or Breast Feeding
As with any drug, ask a doctor before use if pregnant or breast-feeding.
As with any drug, ask a doctor before use if pregnant or breast-feeding.
Otc - Ask Doctor
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.
- 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.
Consult a physician if:
Otc - Keep Out Of Reach Of Children
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.
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.
Otc - Do Not Use
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.
Do not use if imprinted tamper-evident bottle band is broken or missing.
Do not use if imprinted tamper-evident bottle band is broken or missing.
Other
A persistent cough may be a sign of a serious condition.
The inner packaged bottle is child-resistant. 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.
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.
The inner packaged bottle is child-resistant. 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.
*CLAIMS BASED ON TRADITIONAL
HOMEOPATHIC PRACTICE, NOT ACCEPTED
MEDICAL EVIDENCE. NOT FDA EVALUATED.
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.
Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.
Directions
- Measure only with the dosing cup provided
- Do not use dosing cup with other products
- On dosing cup, mL = milliliter, tsp = teaspoon
- 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 up to 6 times per day (every 4 hours) |
Children 6 years to under 12 years | 10 mL or 2 teaspoons up to
6 times per day (every 4 hours) |
Adults and children 12 years and over | 15 mL or 3 teaspoons up to
6 times per day (every 4 hours) |
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.
Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Questions Or Comments?
(800) 624-9659
Principal Display Panel - Kit Carton
NDC 54973-3381-1
HOMEOPATHIC
Ages
2-12
NATURAL
RELIEF
SINCE 1903
Hyland's
4 Kids
Cold'n Mucus*
Loosens mucus in chest, throat and nose
Day & Night Value Pack
DAYTIME
Mucus & Congestion
Runny Nose
Cough
ALCOHOL FREE
SUGAR FREE
DYE FREE
4 FL. OZ. (118 mL) Daytime
NIGHTTIME
Mucus & Congestion
Occasional Sleeplessness
Runny Nose
Cough
LESS THAN 0.2% ALCOHOL
SUGAR FREE
DYE FREE
4 FL. OZ. (118 mL) Nighttime
8 FL. OZ. (236 mL) TOTAL
* Please review the disclaimer below.
