NDC 29485-7007 Allergy

Diphenhydramine Hcl

NDC Product Code 29485-7007

NDC Code: 29485-7007

Proprietary Name: Allergy 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.

Product Characteristics

Color(s):
PINK (C48328 - PINK)
Shape: OVAL (C48345)
Size(s):
11 MM
Imprint(s):
PH25

NDC Code Structure

  • 29485 - Mechanical Servants, Llc
    • 29485-7007 - Allergy

NDC 29485-7007-6

Package Description: 6 POUCH in 1 PACKAGE > 2 TABLET in 1 POUCH

NDC Product Information

Allergy with NDC 29485-7007 is a a human over the counter drug product labeled by Mechanical Servants, Llc. The generic name of Allergy is diphenhydramine hcl. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Mechanical Servants, Llc

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.

Allergy 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.

  • DIPHENHYDRAMINE HYDROCHLORIDE 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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • TALC (UNII: 7SEV7J4R1U)

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: Mechanical Servants, Llc
Labeler Code: 29485
FDA Application Number: part341 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: 03-13-2019 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.

Allergy 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 caplet)Diphenhydramine HCl (25 mg)

Otc - Purpose

Antihistamine

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergiessneezingnasal congestionrunny noseitchy, watery eyesTemporarily relieves these symptoms due to common coldrunny nosesneezing

Warnings

  • Do not useto make a child sleepywith any other product containing Diphenhydramine, even one used on the skin

Ask A Doctor Before Use If You Have

  • Trouble urinating due to an enlarged prostate glanda breathing problem such as emphysema or chronic bronchitisglaucoma

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking sedatives or tranquilizers

When Using This Product

  • Avoid alcoholic drinksmarked drowsiness may occurexcitability may occur, especially in childrenalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machinery

If Pregnant Or Breast-Feeding

Ask a health professional before use

Keep Out Of The Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Take every 4 to 6 hours, or as directed by a doctordo not take more than 6 doses in 24 hoursadults and children 12 years and over         1 to 2 tabletschildren 6 to under 12 years                       1 tabletchildren under 6 years                               ask a doctor

Inactive Ingredients

Colloidal silicon dioxide, corn starch, D & C red # 27 Aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

* Please review the disclaimer below.

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