Label: ATUSS DA- brompheniramine maleate, chlophedianol hydrochloride, pseudoephedrine hydrochloride 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 November 2, 2021

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    (in each 5mL teaspoonful)

    Brompheniramine Maleate 2 mg

    Chlophedianol Hydrochloride 12.5 mg

    Pseudoephedrine Hydrochloride 30 mg

  • PURPOSE

    Purpose

    Antihistamine

    Cough Suppressant

    Nasal Decongestant

  • INDICATIONS & USAGE

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

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

  • WARNINGS

    Warnings

    Do not exceed recommended dosage.

  • DO NOT USE

    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 physician or pharmacist before taking this product.
  • ASK DOCTOR

    Ask a physician before use if you have

    • 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
    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
  • ASK DOCTOR/PHARMACIST

    Ask a physician or pharmacist before use if you are taking sedatives or tranquilizers.

  • WHEN USING

    When using this product

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

    Stop use and ask a physician 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. These could be signs of a serious condition.
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    Do not exceed recommended dosage.

    Adults and children 12 years of age and over:

    2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teapoonfuls (40 mL) in

    24 hours.

    Children 6 to under

    12 years of age:

    1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls (20 mL) in

    24 hours.

    Children under

    6 years of age:

    Consult a physician

  • STORAGE AND HANDLING

    Other information

    Store at 59° - 86°F (15° - 30°C)

  • INACTIVE INGREDIENT

    Inactive ingredients

    Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

  • QUESTIONS

    Questions? Comments?

    Call your physician for medical advice. Serious side effects associated with this product may be reported to this number. 1-888-206-5525, 8 am - 5 pm, M-F EST

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    MAGNA

    Phamaceuticals, Inc.

    Accountability.

    Louisvill, KY 40299

    magnaweb.com

    Rev. 01/18

  • ATUSS DA 4fl oz (118 mL) Bottle Label

    Atuss DA Labeling

  • INGREDIENTS AND APPEARANCE
    ATUSS DA 
    brompheniramine maleate, chlophedianol hydrochloride, pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58407-252
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 5 mL
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE12.5 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58407-252-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/20/2018
    2NDC:58407-252-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product11/20/2018
    3NDC:58407-252-016 in 1 CARTON11/20/2018
    315 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/20/2018
    Labeler - Magna Pharmceuticals, Inc. (620988360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodfield Pharmaceutical, LLC079398730manufacture(58407-252)
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