FAMILY CARE COUGH NIGHTTIME- dextromethorphan hydrobromide, and doxylamine succinate liquid 
United Exchange Corp.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients (in each 30 mL dose cup)                             Purpose

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

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

Uses temporarily relieves cold symptoms: 

Warnings

Do not use

Ask a doctor before use if you have

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

When using this product

Stop use and ask a doctor if

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.

Directions

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

Other information

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

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703

Made in Korea

image description

FAMILY CARE COUGH NIGHTTIME 
dextromethorphan hydrobromide, and doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-625
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-625-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/20/2015
Labeler - United Exchange Corp. (840130579)

Revised: 7/2015
Document Id: 93c6e124-2680-44c9-87eb-3786900c8781
Set id: a43ec952-6841-4729-aded-9a7affe9d411
Version: 1
Effective Time: 20150720
 
United Exchange Corp.