NDC 0904-7688 Anu-med

Phenylephrine Hydrochloride And Fat, Hard

NDC Product Code 0904-7688

NDC 0904-7688-22

Package Description: 12 SUPPOSITORY in 1 CARTON

NDC Product Information

Anu-med with NDC 0904-7688 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Anu-med is phenylephrine hydrochloride and fat, hard. The product's dosage form is suppository and is administered via rectal form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.

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.

Anu-med 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.

  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
  • FAT, HARD 1.77 g/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.

  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • STARCH, CORN (UNII: O8232NY3SJ)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Rectal - Administration to the rectum.

Product Labeler Information

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

Labeler Name: Major Pharmaceuticals
Labeler Code: 0904
Marketing Category: UNAPPROVED DRUG OTHER - 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: 04-01-1996 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 07-31-2020 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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.

Anu-med 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

Distributed by:MAJOR® PHARMACEUTICALS17177 N Laurel Park Drive, Suite 233Livonia, MI 48152 USA

Otc - Purpose

Active ingredients (in each suppository)PurposesHard Fat 88.7%ProtectantPhenylephrine HCl 0.25%Vasoconstrictor

Uses

  • Temporarily shrinks hemorrhoidal tissuetemporarily relieves the itching, burning and discomfort associated with hemorrhoids

Warnings

For rectal use only

Otc - Ask Doctor

  • Ask a doctor before use if you haveheart diseasethyroid diseasehigh blood pressurediabetestrouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression

Otc - When Using

When using this product, do not use more than directed

Otc - Stop Use

  • Stop use and ask a doctor ifbleeding occurscondition worsens or does not improve within 7 days

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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.gently dry by patting or blotting with a tissue or a soft cloth before insertion of suppository.detach one suppository from the stripseparate the two tabs of the white plastic wrapwith thumb and forefinger of each hand, grasp the tabs and peel downward, unwrapping the suppositoryinsert one suppository into the rectumadults and children 12 years and over: insert one suppository rectally up to 4 times dailychildren under 12 years: ask a doctor

Other Information

Store below 30°C (86°F) to avoid melting.

Inactive Ingredients

Corn starch, methylparaben, propylparaben

* Please review the disclaimer below.