FAMILY CARE COLD AND FLU NIGHTTIME- acetaminophen, 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

Acetaminophen 650 mg....................................................Pain reliever/fever reducer

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

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

Uses

temporarily relieves common cold/flu symptoms:

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Sore throat warning: if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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, ask a health professional before use.

Keep our of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

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

children 4 to under 12 yrs: ask a doctor

children under 4 yrs: do not use

Other information

Inactive ingredietns

acesulfame potassium, alcohol, citric acid hydrate, FD&C Green No. 3, FD&C No. 5, glycerin, high fructose corn syrup, L-menthol, methylparaben, mint essence, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate hydrate, sodium chloride, sodium saccharin

Distributed by:

United Exchange Corp.

Cerritos, CA 90703 U.S.A.

Made in Korea

image description

FAMILY CARE COLD AND FLU NIGHTTIME 
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-629
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ALCOHOL (UNII: 3K9958V90M)  
HYDROXYCITRIC ACID (UNII: 8W94T9026R)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-629-04118 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 finalpart34107/21/2015
Labeler - United Exchange Corp. (840130579)

Revised: 7/2015
Document Id: d9ec2557-0197-4f78-bca2-7d299bc04a16
Set id: 85e15203-6d84-4361-877a-7342f070b938
Version: 1
Effective Time: 20150722
 
United Exchange Corp.