Label: DEXBROMPHENIRAMINE-DM-PHENYLEPHRINE 2-15-7.5- dexbrompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid

  • NDC Code(s): 83521-111-16
  • Packager: AddGen Pharmaceuticals, Inc.
  • 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 July 9, 2023

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  • Active ingredients

    (in each 5 mL teaspoonful)

    Dexbrompheniramine Maleate 2 mg

    Dextromethorphan Hydrobromide 15 mg

    Phenylephrine Hydrochloride 7.5mg

  • Purpose

    Antihistamine
    Antitussive
    Nasal Decongestant

  • Uses

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

    • runny nose
    • sneezing
    • itching of nose or throat
    • itchy, watery eyes
    • cough due to minor throat and bronchial irritation
    • 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 taking 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
    • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
    • a cough that occurs with too much phlegm (mucus)
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes

    Ask a doctor or pharmacist before use

    if you are

    taking sedatives or tranquilizers.

    When using this product

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

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
    • new symptoms occur

    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

    Do not exceed recommended dosage. 

    Adults and
    children 12
    years of age
    and over:     		1 teaspoonful (5 mL)
    every 4 to 6 hours,
    not to exceed 6
    teaspoonfuls in a 24
    hours
    Children 6 to
    under 12 years
    of age:     		1/2 teaspoonful
    (2.5 mL) every 4 to 6
    hours, not to exceed
    3 teaspoonfuls in 24 hours
    Children under
    6 years of age:
    		Consult a doctor.
  • Other information

    Store at 59° - 86°F (15° - 30°C)

  • Inactive ingredients

    Anhydrous Citric Acid, Glycerin, Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol Solution.

  • Questions? Comments?

    Serious side effects associated with use of this product may be reported to this number.
    Call 1-800-882-1041
    Mon. - Fri. (8 a.m. to 5 p.m. CST).

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DEXBROMPHENIRAMINE-DM-PHENYLEPHRINE 2-15-7.5 
    dexbrompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83521-111
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE2 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE7.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83521-111-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2023
    Labeler - AddGen Pharmaceuticals, Inc. (118994799)
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