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Product NDC Code | 84126-311 | ||||
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Drug Name | Vicks nyquil kids free of artificial dyes and sugar cold and cough plus runny nose |
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Type | Brand | ||||
Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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Active Ingredients |
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Route | ORAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 2685488 | ||||
Application Number | M012 | ||||
Labeler Name | The Procter & Gamble Manufacturing Company | ||||
Packages |
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Overdosage of VICKS NyQuil Kids FREE OF ARTIFICIAL DYES AND SUGAR COLD and COUGH plus RUNNY NOSE
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 15 mL) Diphenhydramine HCl 12.5 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions take only as directed only use the 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
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 |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, flavor, glycerin, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily relieves common cold symptoms: cough due to minor throat & bronchial irritation cough to help you sleep runny nose & sneezing
Purpose
Information about the drug product’s indications for use.Purpose Antihistamine/Cough suppressant
Spl product data elements
Usually a list of ingredients in a drug product.VICKS NyQuil Kids FREE OF ARTIFICIAL DYES AND SUGAR COLD and COUGH plus RUNNY NOSE Diphenhydramine Hydrochloride SODIUM BENZOATE ANHYDROUS CITRIC ACID WATER SACCHARIN SODIUM SODIUM CITRATE GLYCERIN SORBITOL SUCRALOSE POLYSORBATE 20 PROPYLENE GLYCOL SODIUM CHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE The product is clear.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL VICKS® NyQuil™ Kids FREE OF ARTIFICIAL DYES & SUGAR COLD & COUGH + RUNNY NOSE Diphenhydramine HCl Sneezing, Runny Nose, Cough AGES 6+ 6 FL OZ (177 mL) 311
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINKBAND SEAL AROUND THE NECK IS BROKEN OR MISSING
MADE IN CANADA DIST. BY: PROCTER & GAMBLE CINCINNATI, OH 45202
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have 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 occurs with smoking, asthma, chronic bronchitis or emphysema
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use with any other product containing diphenhydramine, even one used on skin to make a child sleepy
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-362-1683
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if 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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product 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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information each 15 mL contains: sodium 44 mg store at no greater than 25°C
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Do not use with any other product containing diphenhydramine, even one used on skin to make a child sleepy
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API