Medication Guide App

Lodrane D

Dosage form: capsule
Ingredients: BROMPHENIRAMINE MALEATE 4mg, PSEUDOEPHEDRINE HYDROCHLORIDE 60mg
Labeler: ECR Pharmaceuticals
NDC Code: 0095-0860

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

LODRANE® D Capsules
(Antihistamine-Decongestant)

Active ingredient

Each green and white, LODRANE D capsule contains:

Brompheniramine maleate ............... 4 mg
Pseudoephedrine hydrochloride .... 60 mg

In an immediate release formulation.

Purpose
  • Antihistamine
  • Nasal Decongestant

Uses

LODRANE D capsules are indicated for the temporary relief of symptoms associated with allergic rhinitis, including runny nose, sneezing, itching of the nose or throat, itchy watery eyes, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies. Promotes nasal and/or sinus drainage.

Warnings

Do not exceed recommended dosage. Do not use if you have had an allergic reaction to any of the ingredients in this product. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. Do not use 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. May cause excitability especially in children. Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis. May cause drowsiness. Alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use Caution when driving a motor vehicle or operating machinery. Do not give this product to children under 12 years except under the advice and supervision of a physician. If pregnant or breast feeding ask a healthcare professional before use.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Directions

LODRANE D Capsules: Adults and children over 12 years of age: One capsule every 4 to 6 hours, not to exceed 4 capsules in 24 hours.

Inactive ingredients

Lactose monohydrate, magnesium stearate, silicon dioxide, and starch.

How Supplied

LODRANE D Capsules: Bottles of 60 Capsules (NDC 00095-0860-06). Each green and white capsule is imprinted “0860”.

Manufactured for:
ECR Pharmaceuticals
Richmond, Virginia 23255

MI 0860
Rev. 01/2012
OE1280

Package/Label Principal Display Panel - Bottle Label

NDC 00095-0860-06

60 Capsules

LODRANE® D Capsules

EACH CAPSULE CONTAINS:

Brompheniramine maleate ............... 4 mg
Pseudoephedrine hydrochloride .... 60 mg
In an immediate release formulation.

USUAL DOSAGE: Adults and Children Over 12:
1 Capsule every 4-6 hours.
Do not exceed 4 capsules in 24 hours.

For additional information, see accompanying product literature.

KEEP THIS AND ALL MEDICATIONS
OUT OF THE REACH OF CHILDREN.

Store at room temperature.

Manufactured for:
ECR Pharmaceuticals
Richmond, Virginia 23255

ML 0860 LE2127 Rev. 06/2011

LODRANE D 
brompheniramine maleate and pseudoephedrine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0095-0860
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE4 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
SILICON DIOXIDE 
STARCH, CORN 
Product Characteristics
ColorGREEN, WHITEScoreno score
ShapeOVALSize18mm
FlavorImprint Code0860
Contains    
Packaging
#Item CodePackage Description
1NDC:0095-0860-0660 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/21/2011
Labeler - ECR Pharmaceuticals (831116350)
Establishment
NameAddressID/FEIOperations
Elite Laboratories Inc785398728MANUFACTURE(0095-0860)

Revised: 01/2012
 
ECR Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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