FDA Label for Night Time Cough
View Indications, Usage & Precautions
Night Time Cough Product Label
The following document was submitted to the FDA by the labeler of this product Kareway Product, 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.
Active Ingredients (In Each 30 Ml Dose Cup)
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Purpose
Cough suppressant
Antihistamine
Uses
temporarily relieves common cold symptoms:
- cough
- runny nose and sneezing
Warnings
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.
- to make a child sleep
Ask A Doctor Before Use If You Have
- glaucoma
- excessive phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- trouble urinating due to enlarged prostate gland
- a sodium-restricted diet
When Using This Product
- do not use more than directed
- excitability may occur, especially in children.
- marked drowsiness may occur
- 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 lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs 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.
Directions
- use dose cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hours
| adults and children 12 years and over | 2 TBSP (30ml) every 6 hours |
| children under 12 years | ask a doctor |
Other Information
- each 30mL dose cup contains: sodium 36 mg
- store at room temperature
Inactive Ingredients
alcohol, citric acid, FD and C blue no.1, FD and C red no.40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose, sucralose, xanthan gum
Package Label
Night Time Cough Relief
* Please review the disclaimer below.