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cold and allergy

HyVee Inc

Hy-Vee, Inc. Cold and Allergy Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Chlorpheniramine maleate 4 mg

Phenylephrine HCl 10 mg

Purpose

Antihistamine

Nasal decongestant

cold and allergy 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.
  • to make a child sleepy

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

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

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • symptoms do not get better 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 to 6 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

Inactive ingredients

carnauba wax, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-719-9260

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Compare to Actifed® Cold & Allergy Active Ingredients

Cold & Allergy

Chlorpheniramine Maleate, Antihistamine

Phenylephrine HCl, Nasal Decongestant

One Tablet Dose

Nasal Congestion

Runny Nose

Sneezing

Itchy, Watery Eyes

Actual Size

cold and allergy
Cold and Allergy Carton Image #1 Cold and Allergy Carton Image #2

cold and allergy

Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42507-139
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
carnauba wax
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol
POLYVINYL ALCOHOL
SILICON DIOXIDE
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 8 mm L358 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:42507-139-62 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2006-12-02


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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