ShopRite Childrens Cold and Cough

Wakefern Food Corporation

ShopRite Children’s Cold & Cough Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 5 mL teaspoonful)
• Purpose
• ShopRite Childrens Cold and Cough Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• ShopRite Childrens Cold and Cough Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL teaspoonful)

Brompheniramine maleate, USP 1 mg

Dextromethorphan HBr, USP 5 mg

Phenylephrine HCl, USP 2.5 mg

Purpose

Antihistamine

Cough suppressant

Nasal decongestant

ShopRite Childrens Cold and Cough 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):
• •sneezing
• •itching of the nose or throat
• •runny nose
• •itchy, watery eyes
• •temporarily restores freer breathing through the nose

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

• •a breathing problem such as emphysema or chronic bronchitis
• •glaucoma
• •thyroid disease
• •high blood pressure
• •heart disease
• •diabetes
• •cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
• •cough that occurs with too much phlegm (mucus)
• •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
• •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 for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

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

• •do not take more than 6 doses in any 24-hour period

Other information

• •each teaspoon contains: sodium 2 mg
• •store at 20°-25°C (68°-77°F)
• •not a USP elixir

Inactive ingredients

citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol

Questions or comments?

1-800-SHOPRITE

Principal Display Panel

Compare to: Active Ingredients in Dimetapp® Cold & Cough

Children’s

AGES 6 & UP

COLD & COUGH

ANTIHISTAMINE

(Brompheniramine Maleate)

COUGH SUPPRESSANT

(Dextromethorphan HBr)

NASAL DECONGESTANT

(Phenylephrine HCl)

MULTI-SYMPTOM

Relieves: Coughing, Nasal Congestion, Runny Nose, Itchy, Watery Eyes & Sneezing

Alcohol Free

Grape flavor

4 FL OZ (118 mL)