Label: MICLARA DM- dextromethorphan hbr, phenylephrine hcl, triprolidine hcl liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 26, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    MICLARA LQ LIQUID

    Drug Facts

  • Active ingredients

    (in each 5 mL teaspoonful)

    Dextromethorphan HBr       20mg

    Phenylephrine HCl             10mg

    Triprolidine HCl             2.5 mg

  • Purpose

  • Uses

    temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

    • cough due to minor throat or bronchial irritation
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • nasal congestion
    • reduces swelling of nasal passages
  • Warnings

    Do not exceed recommended dosage.

    Do not use this product

    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 giving this product.

    Ask a doctor before use if you have 

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • heart disease
    • high blood pressure
    • a cough that occurs with too much phlegm (mucus)
    • a persistent chronic cough such occurs with smoking, asthma, chronic bronchitis, or emphysema

     

    Ask a doctor before use

    if you are taking sedatives or tranquilizers.

    When using this product

    • excitability may occur, especially in children
    • may cause drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • new symptoms occur
    • nervousness, dizziness, or sleeplessness occur
    • Cough or nasal congestion lasts for more than 1 week, tends to recur or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

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

    Keep out of the reach of children.

    In case of accidental overdose seek professional help or contact a Poison Control Center immediately.

  • Directions

    Do not exceed recommended dosage.

    AgeDose
    Adults and children 12 years of age and older:1 teaspoonful (5mL) every 4 hours, not to exceed 4 teaspoonfuls (20mL) in a 24-hour period or as directed by a doctor
    Children 6 to under 12 years of age:½ teaspoonful (2.5mL) every 4 hours, not to exceed 2 teaspoonfuls (10mL) in a 24-hour period or as directed by a doctor
    Children under 6 years of age:Consult a doctor
  • Other information

    Store at 59° - 86°F (15° - 30°C)

  • Inactive ingredients

    Bubble gum flavor, citric acid, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose.

  • Questions? Comments?

    Serious side effects associated with use of this product may be reported to this number. Call 1-888-981-8337 Mon - Fri (8 a.m. to 5 p.m. CST)

  • PRINCIPAL DISPLAY PANEL

    NDC 70868-740-16
    MICLARA DM
    Bubble gum flavor
    16 fl oz (473 mL)

    PRICIPAL DISPLAY PANEL
NDC 70868-740-16
MICLARA DM
Bubble gum flavor
16 fl oz (473 mL)

  • INGREDIENTS AND APPEARANCE
    MICLARA DM 
    dextromethorphan hbr, phenylephrine hcl, triprolidine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70868-740
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70868-740-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/01/2020
    Labeler - Key Therapeutics (080318791)
    Establishment
    NameAddressID/FEIBusiness Operations
    TG United172837085manufacture(70868-740)