Active Ingredient (In Each Chewable Gel) Daytime
Dextromethorphan HBr 10 mg
Daytime Nighttime Chewable Kit
FDA Label NDC 0363-9393
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Daytime Nighttime Chewable (NDC 0363-9393). 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 ingredient (in each chewable gel) daytime, active ingredients for (in each chewable gel) nighttime, purposes for day time, purpose for night time, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients For (In Each Chewable Gel) Nighttime
Dextromethorphan HBr 10 mg
Doxylamine Succinate 6.25 mg
Purposes For Day Time
Cough suppressant
Purpose For Night Time
Cough suppressant
Antihistamine
Uses
DAYTIME
- temporarily relieves cough due to minor throat and bronchial irritation
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- controls cough to help you get to sleep
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itching of the nose or throat
- sneezing
- itchy, watery eyes
NIGHTTIME
Do Not Use
DAYTIME
- 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 sleepy
- 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
NIGHTTIME
Ask A Doctor Before Use If You Have
DAYTIME
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
- 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
NIGHTTIME
Ask A Doctor Or Pharmacist Before Use If You Are
NIGHTTIME
taking sedatives or tranquilizers
When Using This Product
DAYTIME
do not use more than directed.
NIGHTTIME
- do not exceed recommended dosage
- 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
DAYTIME / NIGHTTIME
cough lasts more than 7 days, comes back, or occurs with fever, or headache that lasts. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
DAYTIME NIGHTTIME
ask a health professional before use.
Keep Out Of Reach Of Children.
DAYTIME / NIGHTTIME
In case of overdose, get medical help or contact a Poison Control Center(1-800-222-1222) right away.
Directions
DAYTIME / NIGHTTIME
- take every 4 hours or as directed by a doctor
- chew thoroughly before swallowing
- adults and children 12 years of age and over: 2 chewable gels every 4 hours, not to exceed 12 chewable gels in any 24-hour period
- children 6 years of age and over: 1 chewable gel every 4 hours, not to exceed 6 chewable gels in any 24-hour period
- children under 6 years of age: do not use
Other Information
DAYTIME
- each chewable gel contains: sodium 8 mg
- store between 20-25°C (68-77°). Do not refrigerate
- each chewable gel contains sodium 6 mg
- store between 20-25°C (68-77°F). Do not refrigerate
NIGHTTIME
Inactive Ingredient
DAYTIME
alcohol, ammonium glycyrrhizate, citric acid anhydrous, corn syrup, FD&C Blue No. 1, FD&C red # 40, flavors, glycerin, glycyrrhizin, malic acid, maltodextrin, medium-chain triglycerides, pectin, propylene glycol, purified water, sorbitol solution, sucralose, sucrose, trisodium citrate dihydrate
NIGHTTIME
alcohol, ammonium glycyrrhizate, citric acid anhydrous, corn syrup, FD&C blue #1, FD&C Red #40, flavors, glycerin, glycyrrhizin, malic acid, maltodextrin, pectin, propylene glycol, purified water, sucralose, sucrose, trisodium citrate dihydrate
Questions Or Comments?
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**Compare to the active ingredient in Mucinex® Children's Mighty Chews Cough Daytime
Children's
DayTime Mucus
Dextromethorphan HBr USP, 10 mg
Cough Suppressant
- Controls cough
- Up to 4-hours of relief
- Controls cough to help you get to sleep
- Relieves chest congestion
For ages 6 years and over
Alcohol Free
Solid Chewable Gels
MIXED BERRY FLAVOR
NightTime
*Compare to the active ingredient in Mucinex® Children's Mighty Chews Cough Nighttime
Children's
Nighttime Mucus
Dextromethorphan HBr 10 mg
Cough suppressant
Doxylamine Succinate
Antihistamine
For ages 6 years and over
Nighttime relief
Solid Chewable Gels
MIXED BERRY FLAVOR
**This product is not manufactured by RB Health (US) LLC, distributor of Mucinex® Children's Mighty Chews Cough Nighttime
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.
DISTRIBUTED BY WALGREENS
Product Label
WALGREENS Daytime Nighttime Chewable Gels Mixed Berry Flavor
* Please review the disclaimer below.
