Cold and Allergy description, usages, side effects, indications, overdosage, supplying and lots more!

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Cold and Allergy

Care One (American Sales Company)
P and L Development of New York Corporation

DRUG FACTS


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 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
  • glaucoma
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • thyroid disease
  • 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 use more than directed
  • drowsiness may occur
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • 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 are accompanied by 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

Cold and Allergy Other information

  • store at 15o- 30o C (59o- 86o F)
  • *This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. owner of the registered trademark Actifed® Cold & Allergy

Inactive ingredients

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

Principal Display Panel

Compare to the active ingredients of Maximum strength Actifed® Cold & Allergy *

COLD & ALLERGY

Chlorpheniramine Maleate 4 mg ANTIHISTAMINE

Phenylephrine HCl 10 mg NASAL DECONGESTANT

One tablet dose

Relieves:

  • Nasal Congestion, Runny Nose
  • itchy, watery eyes
  • sneezing

Gluten Free

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT

Distributed by: American Sales Company

4201 walden avenue, Lancaster, NY 14086

www.care1.com

Product Label

Cold and Allergy
Cold and allergy

Cold and Allergy

Chlorpheniramine maleate, Phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41520-890
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
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

Color Size Imprint Code Shape
WHITE 7 mm T127 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:41520-890-24 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-06-29


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