NDC 0095-0860 Lodrane D

NDC Product Code 0095-0860

NDC 0095-0860-06

Package Description: 60 CAPSULE in 1 BOTTLE

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

NDC Product Information

Lodrane D with NDC 0095-0860 is a product labeled by Ecr Pharmaceuticals. The generic name of Lodrane D is . The product's dosage form is and is administered via form.

Labeler Name: Ecr Pharmaceuticals

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.

  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)

Product Labeler Information

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

Labeler Name: Ecr Pharmaceuticals
Labeler Code: 0095
Start Marketing Date: 10-21-2011 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

Brompheniramine

Brompheniramine is pronounced as (brome fen ir' a meen)

Why is brompheniramine medication prescribed?
Brompheniramine relieves red, irritated, itchy, watery eyes; sneezing; and runny nose caused by allergies, hay fever, and the common cold. Brompheniramine helps control s...
[Read More]
Pseudoephedrine

Pseudoephedrine is pronounced as (soo doe e fed' rin)
Why is pseudoephedrine medication prescribed?
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseud...
[Read More]

* Please review the disclaimer below.

Lodrane D 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

Otc - Purpose

Active ingredients (in each capsule)PurposeBrompheniramine maleate 4 mgAntihistaminePseudoephedrine HCl 60 mgNasal decongestant

Uses

  • ▪temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies▪temporarily relieves these symptoms due to hay fever (allergic rhinitis):▪runny nose▪sneezing▪itchy, watery eyes▪itching of the nose or throat▪temporarily restores freer breathing through the nose

Do Not Use

  • ▪in a child under 12 years of age▪to sedate a child or to make a child sleepy▪if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

  • ▪heart disease▪high blood pressure▪thyroid disease▪diabetes▪glaucoma▪trouble urinating due to an enlarged prostate gland▪breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are

  • ▪taking any other oral nasal decongestant or stimulant▪taking sedatives or tranquilizers

When Using This Product

  • ▪do not use more than directed▪drowsiness may occur▪avoid alcoholic beverages▪alcohol, sedatives, and tranquilizers may increase drowsiness▪be careful when driving a motor vehicle or operating machinery▪excitability may occur, especially in children

Stop Use And Ask A Doctor If

  • ▪you get nervous, dizzy, or sleepless▪symptoms do not improve within 7 days or are accompanied by fever

Otc - Pregnancy Or Breast Feeding

If pregnancy 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.

Directions

  • ▪Do not take more than 4 capsules in any 24-hour period▪Adults and children 12 years of age and over: One capsule every 4 to 6 hours, not to exceed 4 capsules in 24 hours.▪Children under 12 years of age: Do not use

Other Information

  • ▪tamper evident: do not use if carton is open or if foil seal under bottle cap is broken or torn▪store at room temperature

Inactive Ingredients

Lactose monohydrate, magnesium stearate, silicon dioxide, starch

* Please review the disclaimer below.