Label: ONLY FOR ALLERGY- chlorpheniramine maleate tablet

  • 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 May 28, 2019

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  • DRUG FACTS

  • Active ingredient (in each tablet)

    Chlorpheniramine Maleate 4mg

  • Purpose

    Antihistamine

  • Uses:

    • temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:
    • sneezing
    • runny nose
    • itchy, watery eyes
    • itching of the nose or throat
  • Warnings:

    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

    Do not take if
    you are taking sedatives or tranquilizers

    When using this product

    • excitability may occur, especially in children
    • drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic beverages
    • use caution when driving a motor vehicle or operating machinery
    Do not use to make a child sleepy

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

    Keep out of reach of children

    Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions:

    • take with a full glass of water
    • Do not take more than directed
     adults and children 12 years of age and over 1 tablet every 4 to 6 hours, do not take more than 6 tablets in 24 hours
     children 6 to under 12 years of age ½ tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours.
     children under 6 years of age ask a doctor

  • Other Information:

    • Store at room temperature between 20-25°C (68-77°F).
    • protect from excessive heat and moisture
  • Inactive Ingredients:

    D&C yellow#10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch.

  • QUESTIONS OR COMMENTS ?

    1-833-665-9444.

  • SPL UNCLASSIFIED SECTION

    NDC: 73006-113-41

    ANTIHISTAMINE

    Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

    www.onlyfor.com

    Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

    Tear along perforation push product through foil

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    ONLY FOR  ALLERGY
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73006-113
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code S72
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73006-113-411 in 1 CARTON03/29/2019
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/29/2019
    Labeler - O4 Global Trading Usa, Llc (081226861)
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