FDA Label for 4 Kids Complete Cold And Mucus
View Indications, Usage & Precautions
4 Kids Complete 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.
Drug Facts
Otc - Active Ingredient
Active ingredients | Purpose |
Bryonia 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 |
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
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.
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
- infalmation, 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 a 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.
Other
A persistent cough may be a sign of a serious condition.
Sore throat warning: Severe or persistent sore throat or sore accompanied by high fever, headache,nausea and vomitting me ay be serious. Consult a doctor promptly.
Do not use if imprinted tamper-evident bottle band is broken or missing.
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.
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 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) |
Inactive Ingredients
Citric Acid,Glycerine,Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Questions Or Comments?
(800) 624-9659
Otc - Purpose
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.
Recent Major Changes
PDP - updated natural relief icon, applied new Hyland's logo, added 'daytime' beneath the product
name, updated illustration pants to navy blue, scrubbed packaging of spanish copy. Right Panel - updated benefits to: 'our
formulas are safe and always:' (removed mention of effective). Left Panel - updated cross sell section and HPUS
disclaimer. Drug Facts - Revised 'Consult a physician' and added 'sore throat warning' statement to match our Cold 'n
Mucus Nighttime/Cold 'n Cough SKUs (daytime/nighttime), updated tamper-evident statement to: Do not use if imprinted tamper-evident bottle band is broken or missing. Added the following statement before 'in case of emergency': The inner packaged bottle is child-resistant.
Principal Display Panel - 118 Ml Bottle Carton
NDC 54973-3179-1
HOMEOPATHIC
Ages
2-12
Natural
Relief
SINCE 1903
Hyland's®
4 Kids
Cold 'n
Mucus
*
DAYTIME
Loosens mucus in
chest, throat and nose
Mucus & Congestion
Runny Nose
Cough
ALCOHOL FREE
SUGAR FREE
DYE FREE
4 FL. OZ. (118 mL)
* Please review the disclaimer below.