NDC 69721-001 Somnapure Clinical Strength

NDC Product Code 69721-001

NDC 69721-001-30

Package Description: 1 BOTTLE in 1 BOX > 30 TABLET, COATED in 1 BOTTLE

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

NDC Product Information

Somnapure Clinical Strength with NDC 69721-001 is a product labeled by Nutraclick, Llc. The generic name of Somnapure Clinical Strength is . The product's dosage form is and is administered via form.

Labeler Name: Nutraclick, 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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • 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: Nutraclick, Llc
Labeler Code: 69721
Start Marketing Date: 04-09-2015 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 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.

Somnapure Clinical Strength 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

Drug Facts

Active ingredient (in each caplet)Diphenhydramine HCl 50 mg

Otc - Purpose

PurposeNighttime sleep aid

Indications & Usage

Use for relief of occasional sleeplessness

Warnings

Warnings

Otc - Do Not Use

  • Do not usein children under 12 years of agewith any other product containing diphenhydramine, even one used on skin

Otc - Ask Doctor

  • Ask a doctor before use if you havea breathing problem such as emphysema or chronic bronchitisglaucomadifficulty in urination due to enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor before use if you are taking sedatives, tranquilizers, or any other sleep aid.

Otc - When Using

When using this product, avoid alcoholic drinks.

Otc - Stop Use

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, 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.

Dosage & Administration

  • Directionsadults and children 12 years of age and older: 1 caplet (50 mg) at bedtime if needed, or as directed by a doctor

Other Safety Information

  • Other informationstore at 15°-30°C (59°-86°F)

Inactive Ingredient

Inactive ingredients croscarmellose sodium, dicalcium phosphate, FD&C blue no. 1 lake, FD&C blue no. 2 lake, fractionated coconut oil, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polydextrose, silicon dioxide, starch, stearic acid, talc titanium dioxide

Otc - Questions

Questions or comments? Call 1-877-869-3304

* Please review the disclaimer below.