NDC 68210-1510 Diphenhydramine Hydrochloride
NDC Product 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.
NDC Code Structure
- 68210 - Spirit Pharmaceuticals,llc
- 68210-1510 - Diphenhydramine Hydrochloride
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
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
Dosage Form: -
Product Type: 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.
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 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.
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
- Active Ingredients (In Each Liquicap)
- Purpose
- Uses
- Do Not Use
- Ask A Doctor Before Use If You Have
- Otc - Ask Doctor/Pharmacist
- Otc - When Using
- Stop Use And Ask Doctor If
- Otc - Pregnancy Or Breast Feeding
- Otc - Keep Out Of Reach Of Children
- Direction
- Inactive Ingredients
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.