FDA Label for Night Time 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
- PRODUCT LABEL
Night Time Cough Product Label
The following document was submitted to the FDA by the labeler of this product P & L Development, Llc. 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
- a breathing problem or chronic cough that lasts or as occurs with smoking, chronic bronchitis,or emphysema
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- avoid alcoholic drinks
- excitability may occur, especially in children
- marked drowsiness may occur
- 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,come 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 (1-800-222-1222) right away.
Directions
- do not take more than 4 doses in any 24-hour period
- take only as directed
- measure only with dosing cup provided. Do not use any other dosing device
- mL = milliliter
- adults and children 12 years and over: 30 mL every 6 hours
- children under 12 years of age: do not use
Other Information
- each 30 mL contains; sodium 29 mg
- store between 20-25°C (68-77°). Do not refrigerate.
Inactive Ingredients
alcohol, citric acid, FD&C blue 1, FD&C red 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to active ingredients in Vicks'® Nyquil® Cough*
NightTime Cough
all night cough relief
dextromethorphan HBr
doxylamine succinate
relieves
- cough
- runny nose & sneezing
for ages12 and over
alcohol 10%
cherry flavor
FL OZ (mL)
*This product is not manufactured or distributed by The Proctor & Gamble Company. Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
Distributed by:
PL Developments
200 Hicks Street
Westbury, NY 11590
Product Label
READYinCASE NightTime Cough
* Please review the disclaimer below.