FDA Label for 4 Kids Cold And Mucus Nighttime
View Indications, Usage & Precautions
4 Kids Cold And Mucus Nighttime 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.
Otc - Purpose
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.
Otc - Pregnancy 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.
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.
Other
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.
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.
Otc - Do Not Use
Do not use if imprinted tamper-evident bottle band is broken or missing.
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)
* Please review the disclaimer below.