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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
COLD & ALLERGY

Drug Facts

Active ingredients
(in each capsule)
Purpose

Brompheniramine maleate 4 mg

Antihistamine

Pseudoephedrine HCl 60 mg

Nasal 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

Warnings

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

If pregnancy or breast feeding, ask a health professional before use.

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

Questions or comments?

1-800-321-4576

Package/Label Principal Display Panel - Bottle Label

LODRANE®

        D

COLD & ALLERGY

                FOR AGES 12+

Brompheniramine Maleate        Antihistamine
Pseudoephedrine HCl       Nasal Decongestant

Relieves Cold & Allergy Symptoms:
√   Nasal Congestion
√   Runny Nose
√   Sneezing
√   Itchy, Watery Eyes
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)
Registrant - Valeant Pharmaceuticals North America LLC (042230623)
Establishment
NameAddressID/FEIOperations
Elite Laboratories Inc785398728MANUFACTURE(0095-0860)

Revised: 05/2016
 
ECR Pharmaceuticals

See also...

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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