LODRANE D- brompheniramine maleate and pseudoephedrine hydrochloride capsule 
Bausch Health US, LLC

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.

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LODRANE® D
COLD & ALLERGY

Drug Facts

Activeingredients

Active ingredients
(in each capsule)

Brompheniramine maleate 4 mg

Pseudoephedrine HCl 60 mg

Purpose

Antihistamine
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

60 Capsules

Lodrane D - 60 Capsules - Carton
LODRANE D 
brompheniramine maleate and pseudoephedrine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0095-0860
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE4 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorGREEN, WHITEScoreno score
ShapeOVALSize18mm
FlavorImprint Code 0860
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0095-0860-0660 in 1 BOTTLE; Type 0: Not a Combination Product10/21/201112/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/21/201112/31/2018
Labeler - Bausch Health US, LLC (831922468)
Establishment
NameAddressID/FEIBusiness Operations
Elite Laboratories Inc785398728MANUFACTURE(0095-0860)

Revised: 5/2021
Document Id: e294ae33-496a-4b48-91d5-beeac501d377
Set id: 4ae74ab3-c1f7-4347-9833-16553cf9969d
Version: 5
Effective Time: 20210511
 
Bausch Health US, LLC