NDC 76168-066 Zzzsleep

NDC Product Code 76168-066

NDC CODE: 76168-066

Proprietary Name: Zzzsleep What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Product Characteristics

Color(s):
PURPLE (C48327)
Shape: CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
602
Score: 1

NDC Code Structure

NDC 76168-066-02

Package Description: 12 CARTON in 1 BOTTLE > 1 CAPSULE, LIQUID FILLED in 1 CARTON

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Zzzsleep with NDC 76168-066 is a product labeled by Velocity Pharma. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1049909 and 1488693.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
  • SORBITOL (UNII: 506T60A25R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Velocity Pharma
Labeler Code: 76168
Start Marketing Date: 10-15-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)

Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
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Zzzsleep Product Label Images

Zzzsleep Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

(in each tablet) Diphenhydramine HCl 25mg

Purpose

Sleep Aid

Uses

  • For the relief of occasional sleeplessnessReduces time to fall asleep if have difficulty falling asleep

Warnings

  • Do not useIf children under 12 years of agewith any other product containing diphenhydramine, even one used on skinwith other drug that cause drowsiness such as antihistamines and nighttime cold/flu productsDo not use with generic NyQuil®Ask a doctor before use if you have:A breathing problem such as asthma, emphysema, or Chronic bronchitisglaucomadifficulty in urination due to enlargement of the prostate glandheart diseaseYou are taking a diureticAsk a doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid, when using this product :Avoid alcoholic beverages and other drugs that cause drowsinessDrowsiness will occurBe careful when driving a motor vehicle or operating machineryStop use and ask a doctor if sleeplessness persists continuously for more than two weeks.Insomnia may be a symptom of serious underlying medical illness.If pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose Warning: Taking more than directed can cause serious health problems, In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Take only one dose per day (24 hours)- see Overdose warning.Adults and Children 12 years and overOne Dose = Two 25 mg LiquiCaps (50 mg) at bedtime if needed or as directed by a doctor

Other Information

  • Store at 20-25°C (68-77°F)Avoid excessive heat above 40°C(104°F) and high humidityProtect from light

Inactive Ingredients

FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Glycerin, Polyethylene Glycol, Purified Water, Sorbitol, Titanium Dioxide

Questions?

Call 1-855-314-1850TAMPER EVIDENT: This Package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

* Please review the disclaimer below.