FDA Label for Careone Nighttime Cough
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 30 ML)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Careone Nighttime Cough Product Label
The following document was submitted to the FDA by the labeler of this product American Sales 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 (In Each 30 Ml)
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Purpose
Cough suppressant
Antihistamine
Uses
temporarily relieves cold symptoms:
• cough due to minor throat and bronchial irritation• runny nose and sneezing
Do Not Use
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
• glaucoma• cough that occurs with too much phlegm (mucus)• a breathing problem such as emphysema or chronic bronchitis• persistent or chronic cough as occurs with smoking, asthma, or emphysema• trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
• excitability may occur, especially in children• may cause marked drowsiness• avoid alcoholic drinks• be careful when driving a motor vehicle or operating machinery• alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
• take only as directed• only use the dose cup provided• do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over | 30 mL every 6 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
Other Information
• each 30 mL contains: sodium 32 mg• store at 20-25°C (68-77°F)
Inactive Ingredients
alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
Questions Or Comments?
1-800-719-9260
Principal Display Panel
Compare to the active ingredients in Vicks® NyQuil® Cough
NIGHTTIME COUGH
Cough Suppressant-Dextromethorphan HBr
Antihistamine-Doxylamine Succinate
10% ALCOHOL
Relieves:
Cough
Sneezing
Runny Nose
Gluten Free
OUR PHARMACISTS RECOMMEND
Cherry Flavor
12 FL OZ (355mL)
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