Active Ingredients (In Each 15 Ml)
Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Childrens Cough And Congestion, Childrens Cold And Cough Kit
FDA Label NDC 79903-414
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walmart Inc. for the product Childrens Cough And Congestion, Childrens Cold And Cough (NDC 79903-414). 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 15 ml), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough suppressant
Expectorant
Cough suppressant
Antihistamine
Uses
- temporarily relieves these common cold symptoms:
- cough due to minor throat and bronchial irritation
- cough to help you sleep
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- cough due to minor throat and bronchial irritation
- cough to help you sleep
- runny nose and sneezing
temporarily relieves these common cold symptoms:
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.
- 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
Ask A Doctor Before Use If You Have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
- cough that occurs with too much phlegm (mucus)
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Stop Use And Ask A Doctor If
cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.
cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed
- do not exceed 6 doses per 24 hours
- mL = milliliter
- only use the dose cup provided
- do not take more than directed
- do not exceed 6 doses per 24 hours
- mL = milliliter
- only use the dose cup provided
| adults and children 12 years and over | 30 mL every 4 hours |
| children 6 to under 12 years | 15 mL every 4 hours |
| children under 6 years | do not use |
| adults and children 12 years and over | 30 mL every 4 hours |
| children 6 to under 12 years | 15 mL every 4 hours |
| children under 6 years | do not use |
Other Information
- each 15 mL contains: sodium 8 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
- each 15 mL contains: sodium 8 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
anhydrous citric acid, D&C yellow #10, FD&C green #3, FD&C red #40, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum
anhydrous citric acid, D&C yellow #10, FD&C green #3, FD&C red #40, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum
Questions Or Comments?
1-888-287-1915
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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
Principal Display Panel
DAY & NIGHT VALUE PACK
HONEY
FLAVORED
NDC 79903-414-16
equate™ Ages 6+ Day Cough & Congestion Relieves:
8 FL OZ (237 mL) Day | equate™ Ages 6+ Night Cold & Cough Relieves:
8 FL OZ (237 mL) Night |
TAMPER EVIDENT: DO NOT USE IF
PRINTED NECK WRAP IS BROKEN OR
MISSING
Do Not Take Daytime and Nighttime
Products at the Same Time.
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Satisfaction Guaranteed
For more information call
1-888-287-1915
or visit
Walmart.com/help
DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716
50844 ORG022601902019
Equate 44-019020 (Equate 44 019020 1)
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