FDA Label for Cvs Dex-dox Kids Nighttime Cough Suppressant

Otc - Active Ingredient

Active ingredient (in each chewable tablet)

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Otc - Purpose

Purpose

Cough suppressant

Antihistamine

Indications & Usage

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• controls cough to help you sleep
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose
• itching of the nose and throat
• sneezing
• itchy, watery eyes

Warnings

Warnings

Do not use

• to make a child sleep
• 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 week after stopping an MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Otc - Ask Doctor

Ask a doctor before use if you have

• a sodium-restricted diet
• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
• cough accompanied by excessive phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Otc - When Using

When using this product

• do not exceed recommended dosage
• marked drowsiness may occur
• exciteability may occur, expecially in children
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic drings
• use caution when driving a motor vehicle or operating machinery

Otc - Stop Use

Stop use and ask doctor if

• cough persists for more than 7 days, tends to recur, 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.

Overdosage

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Dosage & Administration

Directions

• take every 4 hours or as directed by a doctor
• chew thoroughly before swallowing

adults and children 12 years of age and over - 2 chewable tablets every 4 hours, not to exceed 12 chewable tablets in any 24-hour period

children ages 6 to 12 years - 1 chewable tablet every 4 hours, not to exceed 6 chewable tablets in any 24-hour period

children ages 6 and under - do not use

Other Safety Information

Other information

• each chewable tablet contains: potassium 5 mg and sodium 15 mg
• store in a cool dry place at 20° - 25°C (68° - 77°F)

Inactive Ingredient

Inactive ingredients: Anhydrous citric acid, corn syrup, cranberry juice concentrate, FD&C Blue #1, FD&C Red #40, glycerin, malic acid, medium chain triglycerides, natural & artificial flavors, pectin, sodium chloride, trisodium citrate (anhydrous), sucralose, sucrose, water.

Otc - Questions

Questions? 1-800-245-2898, Monday - Friday, 9AM - 4PM EST