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Chlorpheniramine Maleate, Phenylephrine Hydrochloride

Medically reviewed on January 4, 2018

Dosage form: tablet, coated
Ingredients: CHLORPHENIRAMINE MALEATE 4mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: AAA Pharmaceutical, Inc.
NDC Code: 57344-133

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.

Chlorpheniramine Maleate, Phenylephrine HCl Tablets

Drug Facts

Active ingredients (in each tablet)Purpose
Chlorpheniramine maleate 4 mgAntihistamine
Phenylephrine HCl 10 mgNasal decongestant

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

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 and phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-133
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore2 pieces
ShapeROUNDSize8mm
FlavorImprint CodeT127
Contains    
Packaging
#Item CodePackage Description
1NDC:57344-133-021 BLISTER PACK in 1 CARTON
124 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/22/2012
Labeler - AAA Pharmaceutical, Inc. (181192162)

 
AAA Pharmaceutical, Inc.

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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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