LODRANE D- brompheniramine maleate and pseudoephedrine hydrochloride capsule

Lodrane D by

Drug Labeling and Warnings

Lodrane D by is a Otc medication manufactured, distributed, or labeled by ECR Pharmaceuticals, Valeant Pharmaceuticals North America LLC, Elite Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

PURPOSE

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

PREGNANCY OR BREAST FEEDING

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

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

Questions or comments?

1-800-321-4576

Package/Label Principal Display Panel - Bottle Label LODRANE®         D COLD & ALLERGY                 FOR AGES 12+ Brompheniramine Maleate        AntihistaminePseudoephedrine HCl       Nasal Decongestant Relieves Cold & Allergy Symptoms: √   Nasal Congestion √   Runny Nose √   Sneezing √   Itchy, Watery Eyes

INGREDIENTS AND APPEARANCE

LODRANE D 
brompheniramine maleate and pseudoephedrine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0095-0860
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	4 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	GREEN, WHITE	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	0860
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0095-0860-06	60 in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/21/2011

Labeler - ECR Pharmaceuticals (831116350)

Registrant - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Elite Laboratories Inc		785398728	MANUFACTURE(0095-0860)