FDA Label for Pediacare Childrens Cough And Cold Grape

Other

Drug Facts

Distributed by
CrossingWell Consumer Health
PO Box 440
Cornwall, NY 12518

Otc - Purpose

Uses

• temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • temporarily restores freer breathing through the nose
  
  

Do Not Use

• to sedate a child or to make a child sleepy
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certaindrugs 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

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• a cough that occurs with too much phlegm (mucus)
• a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

• taking any other oral nasal decongestant or stimulant
• taking sedatives or tranquilizers

When Using This Product

• do not use more than directed
• may cause marked drowsiness
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

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 fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not take more than 6 doses in any 24-hour period
• measure only with dosage cup provided
• keep dosing cup with product
• mL = milliliter

age	dose
adults and children 12 years and over	20 mL every 4 hours
children 6 to under 12 years	10 mL every 4 hours
children under 6 years	do not use

Other Information

• store at 20-25°C (68-77°F)

Inactive Ingredients

citric acid anhydrous, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Principal Display Panel - 118 Ml Bottle Carton

Fast Acting

Pedia
Care^®

100% dedicated
to kids™

6 Years & Up

COUGH & COLD

Relieves:

• Stuffy, Runny Nose
• Itchy, Watery Eyes
• Sneezing
• Cough

Brompheniramine maleate - Antihistamine
(2 mg per 10 mL)

Phenylephrine HCl - Nasal decongestant
(5 mg per 10 mL)

Dextromethorphan HBr - Cough suppressant
(10 mg per 10 mL)

Alcohol Free

Grape Flavor

4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton - pediacare 01