COLD AND ALLERGY- chlorpheniramine maleate, phenylephrine hcl tablet 
TOP CARE (Topco Associates LLC)

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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Drug Facts

Active ingredients (in each tablet)

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

Purpose

Antihistamine

Nasal decongestant

Uses

  • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies
    • runny nose
    • sneezing
    • nasal congestion
    • itching of the nose or throat
    • itchy, watery eyes
  • 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
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • do not use more than directed
  • 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

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

If pregnant or breast-feeding,

ask a health care 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 hours
  • do not take more than 6 doses in any 24-hour period
  adults and children 12 years of age and older  take 1 tablet
  children 6 to under 12 years of age  take 1/2 tablet
  children under 6 years of age  consult a doctor
  children under 4 years of age  do not use

Other information

  • each tablet contains: calcium 10 mg
  • store between 15-30ºC (59-86ºF) 

Inactive ingredients

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

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO ACTIFED® COLD & ALLERGY ACTIVE INGREDIENTS*

MAXIMUM STRENGTH

Cold & Allergy RELIEF

CHLORPHENIRAMINE MALEATE, 4 mg - ANTIHISTMINE

PHENYLEPHRINE HCI, 10 mg - NASAL DECONGESTANT

RELIEF OF:

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

TABLETS

For ages 6 years and older

Does not contain Pseudoephedrine

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Actifed® Cold & Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

QUESTIONS? 1-888-423-0139

topcare@topco.com   www.topcarebrand.com

Product Label

Chlorpheniramine maleate 4 mg, Phenylephrine HCI 10 mg

TOPCARE HEALTH Maximum Strength Cold & Allergy relief

COLD AND ALLERGY 
chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-890
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)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize7mm
FlavorImprint Code T127
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-890-6224 in 1 CARTON07/13/201612/30/2022
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/13/201612/30/2022
Labeler - TOP CARE (Topco Associates LLC) (006935977)

Revised: 11/2020
Document Id: bcaf55a6-098e-4122-96ce-db9f47dea1ef
Set id: 5e7d6c08-1123-4034-80cf-c69cf7b1e93c
Version: 4
Effective Time: 20201110
 
TOP CARE (Topco Associates LLC)