NDC 37808-886 Nighttime Sleep Aid

Doxylamine Succinate

NDC Product Code 37808-886

NDC Code: 37808-886

Proprietary Name: Nighttime 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.

Non-Proprietary Name: Doxylamine Succinate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
BLUE (C48333)
Shape: OVAL (C48345)
Size(s):
10 MM
Imprint(s):
44;386
Score: 1

NDC Code Structure

  • 37808 - H E B
    • 37808-886 - Nighttime Sleep Aid

NDC 37808-886-27

Package Description: 2 BLISTER PACK in 1 CARTON > 16 TABLET in 1 BLISTER PACK

NDC Product Information

Nighttime Sleep Aid with NDC 37808-886 is a a human over the counter drug product labeled by H E B. The generic name of Nighttime Sleep Aid is doxylamine succinate. The product's dosage form is tablet and is administered via oral form.

Labeler Name: H E B

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Nighttime Sleep Aid Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DOXYLAMINE SUCCINATE 25 mg/1

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.

  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: H E B
Labeler Code: 37808
FDA Application Number: ANDA040564 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-15-2019 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: 12-31-2020 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: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Nighttime Sleep Aid Product Label Images

Nighttime 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 Tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Uses

Helps to reduce difficulty in falling asleep

Ask A Doctor Before Use If You Have

  • A breathing problem such as asthma, emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate glandglaucoma

Ask A Doctor Or Pharmacist Before Use If You Are

Taking any other drugs.

When Using This Product

  • Avoid alcoholic beveragestake only at bedtime

Stop Use And Ask A Doctor If

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

If 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 (1-800-222-1222) right away.

Directions

  • Adults and children 12 years and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctorchildren under 12 years: do not use

Other Information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKENstore at controlled room temperature 20°-25°C (68°-77°F)see end flap for expiration date and lot number

Inactive Ingredients

Dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

* Please review the disclaimer below.

Previous Code
37808-884
Next Code
37808-890