FAMILY CARE COLD AND FLU MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [UNITED EXCHANGE CORP.]

FAMILY CARE COLD AND FLU MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [UNITED EXCHANGE CORP.]
PDF | XML

NDC 65923-627-04
Set ID 2dc10e39-6bdb-4ce1-b241-1c8aed818290
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corp.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active ingredients (in each 15 mL dose cup)                                               Purpose

    Acetaminophen 325 mg................................................Pain reliever/fever reducer

    Dextromethorphan HBr 10 mg..................................................cough suppressant

    Phenylephrine HCI 5 mg.........................................................Nasal decongestant

  • PURPOSE

    Uses temporarily relieves common cold/flu symptoms:

    • nasal congestion
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
  • WARNINGS

    Warnings

    Liver warning: This product contains acetaminophen. Sever liver damage may occur if

    • adult takes more than 4 (30 mL each) doses in 24 hours, which is the maximum daily amount for this product
    • child takes more than 4 doses (15 mL each) in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

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

  • DO NOT USE

    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 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

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • 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-resitricted diet

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

  • WHEN USING

    When using this product

    • do not use more than directed
  • STOP USE

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • pain or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 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.
  • 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. Overdose warning: Taking more than directed can cause serious health problems. 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

    Directions

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

    adults & children 12 yrs over: 30 mL (2TBSP) every 4 hours

    children 6 to under 12 yrs: 15 mL(1 TBSP) every 4 hours

    children 4 to under 6 yrs: ask a doctor

    children under 4 yrs: do not use

  • STORAGE AND HANDLING

    Other information

    • each 15 mL dose cup contains: sodium 25 mg
    • store at room temperature
  • INACTIVE INGREDIENT

    Inactive ingredients

    citric acid hydrate, D-sorbitol, FD&C Yellow No. 6, glycerin, L-menthol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium chloride, 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

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE COLD AND FLU MULTI SYMPTOM 
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-627
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-627-04118 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 finalpart34107/23/2015
    Labeler - United Exchange Corp. (840130579)