FDA Label for Family Care Cough Nighttime

Otc - Active Ingredient

Active ingredients (in each 30 mL dose cup)                             Purpose

Dextromethorphan HBr 30 mg................................Cough suppressant

Doxylamine succinate 12.5 mg.......................................Antihistamine

Otc - Purpose

Uses temporarily relieves cold symptoms: 

• cough due to minor throat and bronchial irritation
• runny nose and sneezing

Warnings

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.

Otc - Ask Doctor

Ask a doctor before use if you have

• glaucoma
• cough that occurs with excessive phlegm (mucus)
• a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to enlarged prostate gland
• a sodium-restricted diet

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

• excistability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, and tranquilizers may increase drowsiness

Otc - Stop Use

Stop use and ask a doctor if

• cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. A persistent cough may be a sign 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.

Indications & Usage

Directions

• take only as directed
• use dose cup or tablespoon (TBSP)
• do not exceed 4 doses per 24 hrs

adults & children 12 years over: 30 mL (2 TBSP) every 6 hrs

children 4 to under 12 years: ask a doctor

children under 4 years: do not use

Storage And Handling

Other information

• each 30 mL dose cup contains: sodium 7 mg
• store at room temperature

Inactive Ingredient

Inactive ingredients

alcohol, cherry essence, citric acid hydrate, FD&C Blue No. 1, FD&C Red No. 40, glycerin, high fructose corn syrup, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate hydrate, sodium saccharin, xanthan gum

Dosage & Administration

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703

Made in Korea

Package Label.Principal Display Panel

image description - 625