NDC 69168-431 Sleep Aid

Diphenhydramine Hcl

NDC Product Code 69168-431

NDC CODE: 69168-431

Proprietary Name: 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: Diphenhydramine Hcl 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Diphenhydramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, itching, watery eyes, itchy eyes/nose/throat, cough, runny nose, and sneezing. It is also used to prevent and treat nausea, vomiting and dizziness caused by motion sickness. Diphenhydramine can also be used to help you relax and fall asleep. This medication works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its drying effects on such symptoms as watery eyes and runny nose are caused by blocking another natural substance made by your body (acetylcholine). Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Product Characteristics

Color(s):
PURPLE (C48327)
Shape: CAPSULE (C48336)
Size(s):
15 MM
Imprint(s):
PC11
Score: 1

NDC Code Structure

NDC 69168-431-86

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

NDC 69168-431-96

Package Description: 96 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC Product Information

Sleep Aid with NDC 69168-431 is a a human over the counter drug product labeled by Allegiant Health. The generic name of Sleep Aid is diphenhydramine hcl. The product's dosage form is capsule, liquid filled and is administered via oral form.

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

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.

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.


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, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)

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: Allegiant Health
Labeler Code: 69168
FDA Application Number: part338 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: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 09-21-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

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(S)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use(S)

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

Do Not Use

  • For children under 12 years of agewith any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask A Doctor Before Use If

  • A breathing problem such as asthma, emphysema or chronic bronchitisglaucomadifficulty in urination due to enlargement of the prostate gland heart disease

Ask A Doctor Or Pharmacist Before Use If

You are taking sedatives or tranquilizers or any other sleep aid

When Using This Product

  • Avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occurbe careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

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

Pregnancy/Breastfeeding

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 medicalhelp or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Take only one dose per day (24 hours) - see Overdose warningAdults and children 12 years and over: ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor

Other Information

Do not use if blister unit is torn or open.Do not use if imprinted safety seal under cap is broken or missing.

Storage

  • Store at 15-30° C (59-86° F) avoid excessive heat above 40° C (104° F) and high humidity Protect from light

Inactive Ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, white edible ink

Questions

Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST

* Please review the disclaimer below.