FDA Label for Nighttime Cough All Night Cough Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 30 ML)
- PURPOSES
- 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 BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Nighttime Cough All Night Cough Relief 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
Purposes
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 thats lasts or as occurs with smoking, asthma, 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 sedative or tranquilizers.
When Using This Product
- avoid alcoholic drinks
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
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 Breast-Feeding,
ask a health professiuonal before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) right away.
Directions
- keep dosing cup with product
- 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°F). 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
Principal Display Panel
Compare to active ingredients in Vicks® NyQuil® Cough*
Night Time
Cough
all night cough relief
Dextromethorphan HBr
Doxylamine succinate
Relieves:
- cough
- runny nose
- sneezing
for ages 12 and over
nighttime relief
alcohol 10%
FL OZ (mL)
cherry flavor
*This product is not manufactured or distributed by The Procter & 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.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
Product Label
READYINCASE Nighttime Cough Cherry Flavor
* Please review the disclaimer below.