FDA Label for 4 Kids Cold And Cough Nighttime
View Indications, Usage & Precautions
4 Kids Cold And Cough Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product Hyland's Consumer Health 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 | watery/runny nose, cold, hacking cough, painful throat |
Chamomilla 6X HPUS | sensitive, irritable, fussy, nocturnal occasional sleeplessness |
Coffea Cruda 6X HPUS | occasional sleeplessness, restlessness |
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 that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Uses
Temporarily relieves the symptoms of the common cold including cough, runny nose, sneezing, nasal and chest congestion, and sore throat with accompanying 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.
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 medical professional.
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.
Sore Throat Warning
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.
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 - 118 Ml Bottle Carton
NDC 54973-3375-1
HOMEOPATHIC
Ages
2-12
NATURAL
RELIEF
SINCE 1903
Hyland's
4 Kids
Cold'n
Cough*
NIGHTTIME
Chest Congestion
Occasional Sleeplessness
Runny Nose
Sneezing
Cough
ALCOHOL FREE
SUGAR FREE
DYE FREE
4 FL. OZ. (118 mL)
* Please review the disclaimer below.