FAMILY CARE COUGH NIGHTTIME- dextromethorphan hydrobromide, and doxylamine succinate liquid

Family Care Cough Nighttime by

Drug Labeling and Warnings

Family Care Cough Nighttime by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each 30 mL dose cup)                             Purpose

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

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

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.

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

ASK DOCTOR/PHARMACIST

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

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

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.

PREGNANCY OR BREAST FEEDING

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY CARE COUGH NIGHTTIME 
dextromethorphan hydrobromide, and doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-625
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-625-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/20/2015

Labeler - United Exchange Corp. (840130579)