Chlorpheniramine Maleate, Phenylephrine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Chlorpheniramine Maleate, Phenylephrine Hydrochloride

AAA Pharmaceutical, Inc.

Chlorpheniramine Maleate, Phenylephrine HCl Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each tablet) Purpose
Chlorpheniramine maleate 4 mg Antihistamine
Phenylephrine HCl 10 mg Nasal decongestant

Chlorpheniramine Maleate, Phenylephrine Hydrochloride Uses

  • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • nasal congestion
    • itching of the nose or throat
    • sinus congestion and pressure

Warnings

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.

Ask a doctor before use if you have

  • high blood pressure
  • heart disease
  • thyroid disease
  • diabetes
  • 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

  • do not exceed recommended dosage
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with fever

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 (1-800-222-1222).

Directions

  • adults and children 12 years and over: take 1 tablet every 4 hours; do not take more than 6 tablets in 24 hours
  • children under 12 years: do not use this product in children under 12 years of age

Chlorpheniramine Maleate, Phenylephrine Hydrochloride Other information

  • store at 20°-25°C (68°-77°F)
  • retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, dibasic dicalcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, pregelatinized starch, sodium starch glycolate, stearic acid

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton

RESTORE u

NDC 57344-133-02

COMPARE TO THE ACTIVE
INGREDIENTS IN SUDAFED PE®
SINUS + ALLERGY

MAXIMUM
STRENGTH

Sinus & Allergy PE
For Adults

Phenylephrine HCl, Chlorpheniramine Maleate
Nasal Decongestant, Antihistamine

Relieves: • Sinus Pressure & Congestion
• Sneezing, Itchy Eyes & Runny Nose

24 TABLETS

Chlorpheniramine Maleate, Phenylephrine Hydrochloride

Chlorpheniramine Maleate, Phenylephrine Hydrochloride

CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57344-133
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 4 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
Mineral Oil
STARCH, CORN
sodium starch glycolate type a corn
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
WHITE 8 mm T127 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:57344-133-02 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-12-22


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Be sure to consult your doctor before taking any medication!
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