NDC 58805-006 Nightime Sleep Aid

NDC Product Code 58805-006

NDC CODE: 58805-006

Proprietary Name: Nightime Sleep Aid 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):
BLUE (C48333)
Shape: OVAL (C48345)
Size(s):
16 MM
Imprint(s):
206
Score: 1

NDC Code Structure

NDC 58805-006-00

Package Description: 750 BAG in 1 BOX > 1 CAPSULE, LIQUID FILLED in 1 BAG

NDC 58805-006-01

Package Description: 750 BAG in 1 BOX > 30 CAPSULE, LIQUID FILLED in 1 BAG

NDC 58805-006-02

Package Description: 750 BOX in 1 BAG > 48 CAPSULE, LIQUID FILLED in 1 BOX

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

NDC Product Information

Nightime Sleep Aid with NDC 58805-006 is a product labeled by Agile Pharmachem. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1020477.

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)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
  • SORBITOL (UNII: 506T60A25R)
  • POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

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

Labeler Name: Agile Pharmachem
Labeler Code: 58805
Start Marketing Date: 03-31-2014 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...
[Read More]

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Nightime Sleep Aid Product Label Images

Nightime Sleep Aid 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 softgel) Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep aid

Uses

  • For relief of occasional sleeplessness.

Directions

  • Adults and children 12 years and over : one softgel (50 mg) at bed time if needed or as directed by a doctor.children under 12 years:do not use

Warnings

  • Do not usein children under 12 years of age.with any other product containing diphenhydramine, even one used on skinAsk a doctor before use if you haveglaucomatrouble urinating due to an enlarged prostate glanda breathing problem such as emphysema or chronic bronchitisAsk a doctor or pharmacist before use if you are taking sedatives or tranquilizersWhen using this productavoid alcoholic drinksIf pregnant or breast-feeding, 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. (1-800-222-1222)

Other Information

  • Save carton for full directions and warnings

Inactive Ingredients

Blue 1, gelatin, glycerin, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, sorbitol, titanium dioxide and water.

* Please review the disclaimer below.