Topco Allergy

Name: Topco Allergy

Warnings

Do not use

to make a child sleepy

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

  • alcohol, sedatives and tranquilizers may increase drowsiness
  • drowsiness may occur
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery

If pregnant 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

take every 4 to 6 hours, not more than 6 doses in 24 hours

adults and children 12 years of age and over 1 tablet (4 mg)
children 6 to under 12 years of age 1/2 tablet (2 mg)
children 4 to under 6 years of age

do not use unless

directed by a doctor
children under 4 years of age do not use

Principal Display Panel

See New Warning and Dosing Directions

For Fast-Acting Relief

Allergy

Chlorpheniramine Maleate

Antihistamine

4 Hour Relief

Relieves: Runny Nose, Sneezing, Itchy, Watery Eyes, Itchy Throat

Actual Size

Compare to Chlor-Trimeton® active ingredient

Allergy Carton

TOPCARE ALLERGY 
chlorpheniramine maleate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-463
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code L463
Contains     
Packaging
# Item Code Package Description
1 NDC:36800-463-62 1 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 24 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 10/06/1995
Labeler - Topco Associates LLC (006935977)
Revised: 01/2010   Topco Associates LLC

For the Consumer

Applies to chlorpheniramine: oral liquid, oral syrup, oral tablet, oral tablet extended release

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

For Healthcare Professionals

Applies to chlorpheniramine: compounding powder, injectable solution, oral capsule extended release, oral liquid, oral suspension extended release, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release

Nervous system

Central nervous system side effects have included depression resulting in drowsiness in 75% or more of treated patients. Dyskinesias have rarely been reported following chronic use of chlorpheniramine (the active ingredient contained in Topco Allergy) [Ref]

Nearly all patients treated with chlorpheniramine experience drowsiness. This drowsiness may subside in some patients with extended use.

Few cases of dyskinesias and tremors, often of the face, have been reported in patients whose chronic use of chlorpheniramine extended over a period of 3 to 10 years. Some of these cases were only partially relieved by discontinuation of the drug. Haloperidol was successful in relieving symptoms.[Ref]

Gastrointestinal

Gastrointestinal side effects have included dry mouth and constipation in up to one-third of treated patients.[Ref]

Cardiovascular

Cardiovascular side effects have included hypotension, tachycardia, and palpitations.[Ref]

Ocular

Ocular side effects of chlorpheniramine (the active ingredient contained in Topco Allergy) may include blurred vision, diplopia, and dry eyes due to anticholinergic effects.[Ref]

Genitourinary

Genitourinary side effects have included dysuria, urinary hesitancy, and a decreased urine flow. In rare cases, the anticholinergic effect of chlorpheniramine (the active ingredient contained in Topco Allergy) has precipitated acute urinary retention.[Ref]

Hematologic

Hematologic side effects have included bone marrow suppression, thrombocytopenia, and aplastic anemia.[Ref]

A fatal case of agranulocytosis has been reported in a patient taking chlorpheniramine, pseudoephedrine, acetaminophen, dextromethorphan, phenylpropanolamine, and aspirin. Chlorpheniramine was felt to be the cause.[Ref]

Some side effects of Topco Allergy may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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