The following Structured Product Label (SPL) was submitted to the FDA by Hyland's Inc. for the product 4 Kids Cold And Cough Nighttime Natural Grape Flavor (NDC 54973-3377). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, otc - pregnancy or breast feeding, consult a physician if, keep this and all medications out of the reach of children., other, sore throat warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Allium Cepa 6X HPUS,Chamomilla 6X HPUS,Coffea Cruda 6X HPUS,Hepar Sulph Calc 12X HPUS,Hydrastis 6X HPUS
Natrum Muriaticum 6X, Phosphorus 12X HPUS,Pulsatilla 6X HPUS, Sulphur 12X HPUS
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
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
Temporarily relieves the symptoms of the common cold, including: • cough • runny nose • sneezing • nasal and chest congestion • sore throat with accompanying occasional sleeplessness.
As with any drug, ask a doctor before use if pregnant or breast-feeding.
• 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.
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 medical 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 be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659
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 imprinted tamper-evident bottle cap band is broken or missing.
• 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 |
Citric Acid, Glycerine, Glycyrrhiza Extract,Natural Grape Flavor Purified Water, Sodium Benzoate.
(800) 624-9659
NDC 54973-3377-1
HOMEOPATHIC
Ages
2-12
NATURAL
RELIEF
SINCE 1903
Hyland's
4 Kids
Cold 'n Cough*
Nighttime
Natural Grape Flavor
Congestion
Ocassional Sleeplessness
Runny Nose
Sore Throat
Sneezing
Cough
ALCOHOL FREE
SUGAR FREE
DYE FREE
4 FL. OZ. (118 mL)
* Please review the disclaimer below.
