Family care cold and flu multi symptom liquid

Otc - active ingredient section

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

Otc - purpose section

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • running nose and sneezing

Warnings section

Warnings

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

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

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.

Otc - do not use section

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription).
  • If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a presction 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.
  • to make a child sleep

Otc - ask doctor section

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • cough that occurs with too much 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 section

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thining drug warfarin

Otc - when using section

When using this product

  • excitability may occur, especially in chldren
  • 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 and ask a doctor if

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

Otc - pregnancy or breast feeding section

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

Otc - keep out of reach of children section

Keep out 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.

Indications & usage section

Directions

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

Storage and handling section

Other information

  • each 30 mL dose cup contains:
  • potassium 3 mg
  • sodium 7 mg
  • store at room temperature

Inactive ingredient section

Inactive ingredients

acesulfame potassium, alcohol, cherry essence, citric acid hydrate, FD&C Blue No. 1, FD&C Red No. 40, high fructose corn syrup, L-menthol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate hydrate, sodium saccharin

Dosage & administration section

Distributed by:

United Exchange Corp.

Cerritos, CA 90703 U.S.A.

Made in Korea

Ingredients and appearance - Product information

Family care cold and flu multi symptom liquid- Acetaminophen, dextromethorphan hydrobromide, doxylamine succinate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 65923-630
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 650 mgin 30 mL
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 30 mgin 30 mL
Doxylamine succinate ( UNII: V9BI9B5YI2)( Doxylamine - UNII: 95QB77JKPL ) 12.5 mgin 30 mL

Inactive Ingredients

Ingredient Name Code
Acesulfame potassium ( UNII: 23OV73Q5G9)
Alcohol ( UNII: 3K9958V90M)
Citric acid monohydrate ( UNII: 2968PHW8QP)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 40 ( UNII: WZB9127XOA)
High fructose corn syrup ( UNII: XY6UN3QB6S)
Menthol ( UNII: L7T10EIP3A)
Methylparaben ( UNII: A2I8C7HI9T)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Propylene glycol ( UNII: 6DC9Q167V3)
Propylparaben ( UNII: Z8IX2SC1OH)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - United Exchange Corp.( 840130579)

Package label.principal display panel