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cold and allergy relief

Rite Aid

Rite Aid 44-525


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg
Phenylephrine HCl 10 mg

Purpose

Antihistamine
Nasal decongestant

cold and allergy relief Uses

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

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

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improce 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

  • 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 

cold and allergy relief Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid

Principal Display Panel

RITE
AID®
PHARMACY

*Compare to the active ingredients in Actifed® Cold & Allergy Tablets

cold & allergy relief
chlorpheniramine maleate 4 mg, phenylephrine HCl 10 mg
antihistamine & nasal decongestant

relieves:
nasal congestion
runny nose
sneezing
itchy, watery eyes

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

*This product is not distributed or manufactured by McNeil Consumer Healthcare, owner of the registered trademark Actifed® Cold & Allergy Tablets.
50844        REV0612A52522

DISTRIBUTED BY:
Rite Aid
30 Hunter Lane, Camp Hill, PA 17011

cold and allergy relief
Rite Aid 44-525

cold and allergy relief

Chlorpheniramine maleate and Phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11822-5250
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
CROSCARMELLOSE SODIUM
LACTOSE
MAGNESIUM STEARATE
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
WHITE 6 mm 44;525 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 48 in 1 BLISTER PACK
2 NDC:11822-5250-2 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2002-07-22


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Be sure to consult your doctor before taking any medication!
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