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Vicks zzzquil nighttime sleep-aid - Medication Information

Product NDC Code 69423-812
Drug Name

Vicks zzzquil nighttime sleep-aid

Type Brand
Pharm Class Histamine H1 Receptor Antagonists [MoA],
Histamine-1 Receptor Antagonist [EPC]
Active Ingredients
Diphenhydramine hydrochloride 50 mg/30ml
Route ORAL
Dosage Form LIQUID
RxCUI drug identifier 1248354
Application Number M010
Labeler Name The Procter & Gamble Manufacturing Company
Packages
Package NDC Code Description
69423-812-12 354 ml in 1 bottle, plastic (69423-812-12)
69423-812-24 2 bottle, plastic in 1 carton (69423-812-24) / 354 ml in 1 bottle, plastic
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Overdosage of VICKS ZzzQuil NIGHTTIME SLEEP-AID

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.

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each 30 mL dose cup) Diphenhydramine HCl 50 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 one dose (30 mL) per day (24 hours) only use the dose cup provided adults & children 12 yrs & over 30 mL at bedtime if needed or as directed by a doctor children under 12 yrs do not use
adults & children 12 yrs & over30 mL at bedtime if needed or as directed by a doctor
children under 12 yrsdo not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, polysorbate 20, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

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 for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Purpose

Information about the drug product’s indications for use.
Purpose Nighttime sleep-aid

Spl product data elements

Usually a list of ingredients in a drug product.
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl POLYSORBATE 20 GLYCERIN SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCRALOSE WATER XANTHAN GUM ALCOHOL ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE

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 ® ZzzQuil™ NIGHTTIME SLEEP-AID Diphenhydramine HCl Fall Asleep Fast Non-Habit Forming Calming Vanilla Cherry Not for colds or for pain Alcohol 10% 12 FL OZ (354 mL) 812

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 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 a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland

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 for children under 12 years of age with any other product containing diphenhydramine, even one used on skin

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? 1-877-881-5813

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 sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

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 avoid alcoholic beverages

Pregnancy or breast feeding

Pregnancy or Breast feeding
If 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 30 mL dose cup contains: sodium 22 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 for children under 12 years of age with any other product containing diphenhydramine, even one used on skin

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