CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE- chlorpheniramine maleate and phenylephrine hydrochloride tablet, coated 
AAA Pharmaceutical, Inc.

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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RES - 1158 - 2019-0911

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
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
    • nasal congestion

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

Stop use and ask a doctor if

  • nervousnous, 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 of age: 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

Questions or comments?

1-844-705-4384

PRINCIPAL DISPLAY PANEL

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NDC 57344-158-02

†COMPARE TO THE ACTIVE INGREDIENT IN ACTIFED® COLD + ALLERGY

Cold + Allergy

Chlorpheniramine Maleate, Phenylephrine HCl

Antihistamine, Nasal Decongestant

One Tablet Dose

Relieves: • Nasal Congestion • Sneezing • Runny Nose • Itchy, Watery Eyes

Actual Size

24 TABLETS

image description

CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE 
chlorpheniramine maleate and phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-158
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code T127
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57344-158-021 in 1 CARTON06/01/201901/31/2022
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/201901/31/2022
Labeler - AAA Pharmaceutical, Inc. (181192162)

Revised: 11/2021
Document Id: d09e6fef-3f72-386f-e053-2995a90a7b4c
Set id: b413630b-de50-4e32-bf80-05fae8e5eb55
Version: 4
Effective Time: 20211112
 
AAA Pharmaceutical, Inc.