Active Ingredients (In Each 30 Ml)
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Nighttime Cough Relief Liquid
FDA Label NDC 83324-153
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice (chain Drug Marketing Association) for the product Nighttime Cough Relief (NDC 83324-153). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis,or emphysema
- 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
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- 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,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
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- take only as directed
- 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
Principal Display Panel
Nighttime Cough Relief
Dextromethorphan HBr 30 mg
Cough suppressant
Doxylamine succinate 12.5 mg
Antihistamine
relieves
- Cough
- Runny nose
- Sneezing
For ages12 years and over
Nighttime relief
Alcohol 10%
CHERRY FLAVOR
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
Distributed by:
Product Label
QUALITY CHOICE Nighttime Cough Relief Cherry Flavor
* Please review the disclaimer below.
