FDA Label for 2 To 12 Years Childrens Cold And Cough Day And Night Time
View Indications, Usage & Precautions
2 To 12 Years Childrens Cold And Cough Day And Night Time Product Label
The following document was submitted to the FDA by the labeler of this product Rite Aid Hdgrts Corp. 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 - Active Ingredient
Active ingredients | Purpose |
Allium Cepa 6X HPUS | watery/runny nose, cold, hacking cough, painful throat |
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 |
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 |
Other
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
THIS INFORMATION IS BASED UPON TRADITIONAL HOMEOPATHIC PRACTICE. THESE HAVE NOT BEEN REVIEWED BY FOOD AND DRUG ADMINISTRATION
Uses
- temporarily relieves the symptoms of common cold including nasal and chest congestion, runny nose, sore throat, sneezing and cough.
- 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.
As with any drug, ask a doctor before use if pregnant or breast-feeding.
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.
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 - Ask Doctor
Consult a physician if:
- symptoms persistent for more than 7 days or worsen
- inflammation, fever or infection develops
- symptoms are accompanied by high fever (over 101° F)
- cough tends to recur or is accompanied by high fever, rash or persistent headache
- symptoms persistent for more than 7 days or worsen
- inflammation, fever or infection develops
- symptoms are accompanied by high fever (over 101° F)
- cough tends to recur or is accompanied by high fever, rash or persistent headache
Consult a physician if:
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 phlegm (mucus), unless directed by a licensed medical professional.
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.
Directions
- Measure only with the dosing cup provided.
- Do not use dosing cup with other products.
- On dosing cup, mL= milliliter, tsp = teaspoon.
- 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 | 1 teaspoon or 5 mL up to 6 times per day (every 4 hours) |
| Children 6 years to under 12 years | 2 teaspoons or 10 mL up to 6 times per day (every 4 hours) |
| Adults and children 12 years and over | 3 teaspoons or 15 mL up to 6 times per day (every 4 hours) |
| Children 2 years to under 6 years | 1 teaspoon or 5 mL up to 6 times per day (every 4 hours) |
| Children 6 years to under 12 years | 2 teaspoons or 10 mL up to 6 times per day (every 4 hours) |
| Adults and children 12 years and over | 3 teaspoons or 15 mL up to 6 times per day (every 4 hours) |
Inactive Ingredients
Citric Acid, Glycerin, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Citric Acid, Glycerin, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Other Safety Information
TAMPER-EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND OR SEAL UNDER CAP IS BROKEN OR MISSING
Package Label - Kit Carton
CHILDREN'S COLD & COUGH
Sugar Free, Dye Free
Alcohol free
DAYTIME
Cough
Nasal Congestion
Runny Nose
Sore Throat
Sneezing
NIGHTTIME
Cough
Sneezing
Runny Nose
Sleeplessness
Sore Throat
2-12 YEARS
TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)
HOMEOPATHIC
* Please review the disclaimer below.