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Cold and Allergy by Care One (American Sales Company)

Medically reviewed on Nov 22, 2016

Dosage form: tablet
Ingredients: CHLORPHENIRAMINE MALEATE 4mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Care One (American Sales Company)
NDC Code: 41520-890

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.

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
    • 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
  • 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 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 24 hours
 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 (59-86o F)

Inactive ingredients

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

Question or Comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COLD & ALLERGY RELIEF

Antihistamine - Chlorpheniramine Maleate, 4 mg

Nasal Decongestant - Phenylephrine HCI, 10 mg

For Relief of:

Nasal Congestion

Runny Nose

Itchy, Watery Eyes

Sneezing

Gluten Free

TABLETS

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 FOODHOLD, U.S.A., LLC

LANDOVER, MD 20785 • 1-877-846-9949

Product Label

CAREONE Cold & Allergy Relief

COLD AND ALLERGY 
chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-890
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, ANHYDROUS 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize7mm
FlavorImprint CodeT127
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-890-241 BLISTER PACK in 1 CARTON
124 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/29/2011
Labeler - Care One (American Sales Company) (809183973)

 
Care One (American Sales Company)

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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