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Walgreens Nighttime Kids Liquid
FDA Label NDC 0363-6248
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 Co for the product Walgreens Nighttime Kids (NDC 0363-6248). 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 other, active ingredients (in each 15 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each 15 Ml)
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Purpose
Cough suppressant
Antihistamine
Nasal decongestant
Uses
temporarily relieves common cold symptoms:
▪ nasal congestion▪ sinus congestion & pressure▪ cough due to minor throat & bronchial irritation▪ cough to help you sleep▪ runny nose & sneezing▪ reduces swelling of nasal passages▪ temporarily restores freer breathing through the nose▪ promotes nasal and/or sinus drainage
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.▪ to make a child sleepy
Ask A Doctor Before Use If You Have
▪ heart disease▪ high blood pressure▪ thyroid disease▪ diabetes▪ glaucoma▪ trouble urinating due to enlarged prostate gland▪ cough that occurs with too much phlegm (mucus)▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
▪ do not use more than directed.▪ excitability may occur, especially in children▪ marked drowsiness may occur▪ alcohol, sedatives, and tranquilizers may increase drowsiness▪ avoid alcoholic drinks▪ be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
▪ you get nervous, dizzy or sleepless▪ symptoms do not improve within 7 days or occur with a fever▪ cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Directions
▪ take only as directed▪ only use dose cup provided▪ do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over | 30 mL every 4 hrs |
children 6 to under 12 yrs | 15 mL every 4 hrs |
children 4 to under 6 yrs | do not use unless directed by a doctor |
children under 4 yrs | do not use |
Other Information
- each 15 mL contains: sodium 12 mg
- store at room temperature
Inactive Ingredients
Anhydrous citric acid, carboxymethylcellulose sodium, disodium edetate, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, , xanthan gum
Questions?
1-866-467-2748
Principal Display Panel - 236 Ml Bottle Label
Compare to the active ingredients in Kids Vicks® NyQuil™ Honey Cold & Cough + Congestion*
NDC 0363-6248-08
Nighttime
Kid’s
Cold & Cough + Congestion
Doxylamine Succinate, Phenylephrine HCl, Dextromethorphan HBr
- Sneezing, Runny Nose
- Nasal Congestion
- Cough
No Added Alcohol & Acetaminophen Free
Honey Flavor
Naturally and Artificially Flavored
8 FL OZ (236 mL)
*This Product is not manufactured or distributed by Procter & Gamble, the distributor of Kids Vicks® NyQuil™ Honey Cold & Cough + Congestion.
Wag Nighttime Kids Cold & Cough + Congestion 8 Fl Oz 236 mL (69423945)
* Please review the disclaimer below.
