NDC 68210-1510 Diphenhydramine Hydrochloride

  1. Labeler Index
  2. Spirit Pharmaceuticals,llc
  3. NDC: 68210-1510 Diphenhydramine Hydrochloride

NDC Product Code 68210-1510

NDC CODE: 68210-1510

Proprietary Name: Diphenhydramine Hydrochloride 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: 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):
18 MM
Imprint(s):
293
Score: 1

NDC Code Structure

NDC 68210-1510-1

Package Description: 1 BAG in 1 DRUM > 10000 CAPSULE, LIQUID FILLED in 1 BAG

NDC 68210-1510-4

Package Description: 1 BAG in 1 DRUM > 4000 CAPSULE, LIQUID FILLED in 1 BAG

NDC 68210-1510-6

Package Description: 1 BAG in 1 DRUM > 6000 CAPSULE, LIQUID FILLED in 1 BAG

NDC 68210-1510-8

Package Description: 1 BAG in 1 DRUM > 8000 CAPSULE, LIQUID FILLED in 1 BAG

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

NDC Product Information

Diphenhydramine Hydrochloride with NDC 68210-1510 is a product labeled by Spirit Pharmaceuticals,llc. The generic name of Diphenhydramine Hydrochloride is . The product's dosage form is and is administered via form.

Labeler Name: Spirit Pharmaceuticals,llc

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.
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GELATIN (UNII: 2G86QN327L)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Labeler Information

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

Labeler Name: Spirit Pharmaceuticals,llc
Labeler Code: 68210
Start Marketing Date: 06-01-2010 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: 12-31-2017 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".

* Please review the disclaimer below.

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]

* Please review the disclaimer below.

Diphenhydramine Hydrochloride Product Label Images

Diphenhydramine Hydrochloride 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

Other

Drug Facts

Active Ingredients (In Each Liquicap)

Diphenhydramine HCl 50 mg

Purpose

Nighttime Sleep aid

Uses

For relief occasional sleeplessness

Do Not Use

  • For children under 12 years of agewith any other product containing Diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have

  • Glaucomatrouble urinating due to enlarged postage glanda breathing problem such as emphysema or chronic bronchitis

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Otc - When Using

When using this product avoid alcoholic drinks

Stop Use And Ask Doctor If

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.In case of overdose,get medical help or contact a poison control center right away.

Direction

Adults and children 12 years of age and older -1 softgel (50mg) at bedtime if needed; or as directed by doctor

Inactive Ingredients

PEG – 400, Propylene Glycol USP , Gelatin , Sorbitol, FD & C Blue No.1 IH, Purified water

* Please review the disclaimer below.