FDA Label for Childrens Cold And Cough Nighttime
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- CONSULT A PHYSICIAN IF
- KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
- DO NOT USE THIS PRODUCT
- SORE THROAT WARNING
- IN CASE OF EMERGENCY
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- OTHER
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL
Childrens Cold And Cough Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Company. 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
Allium Cepa 6X HPUS
Chamomilla 6X HPUS
Coffea Cruda 6X HPUS
Hepar Sulph Calc 12X HPUS
Hydrastis 6X HPUS
Natrum Muriaticum 6X HPUS
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.
Purpose
Allium Cepa 6X HPUS...................watery/runny nose, cold, hacking cough, sore throat
Chamomilla 6X HPUS...................sensitive, irritable, fussy, 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
Uses
Temporarily relieves the symptoms of the common cold including cough, runny nose, sneezing, nasal or chest congestion or sore throat with accompanying occasional sleeplessness.
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.
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.
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.
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.
In Case Of Emergency
contact a medical professional or Poison Control Center immediately.
Directions
- Shake well before using.
- Measure only with the dosing cup provided.
- Do not use dosing cup with other products.
- On dosing cup, mL = milliliter.
Children 2 years to under 6 years | 5 mL at bedtime and every 4 hours during the night or as necessary |
Children 6 years to under 12 years | 10 mL at bedtime and every 4 hours during the night or as necessary |
Adults and children 12 years and over | 15 mL at bedtime and every 4 hours during the night or as necessary |
Other Information
- Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
- This package is child-resistant.
- Store at room temperature.
- Do not refrigerate.
Inactive Ingredients
Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Questions Or Comments?
1-800-925-4733
Other
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. |
Principal Display Panel - 118 Ml Bottle Label
Walgreens
NDC 0363-9996-01
children's
Nighttime
Dye-Free
Cold & Cough*
DYE FREE SUGAR FREE
ALCOHOL FREE
- Homeopathic
AGES
2-12
YEARS
FLAVOR FREE
4 FL OZ (118 mL)
* Please review the disclaimer below.