Label: FEDRIN- acetaminophen, phenylephrine 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 November 28, 2016

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

  • ACTIVE INGREDIENT

    Active Ingredients (In Each Tablet)

    Acetaminophen 500 mg, Phenylephrine HCl 5 mg

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  • PURPOSE

    Pain reliever/fever reducer, Nasal decongestant

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  • INDICATIONS & USAGE

    Uses:

    For temporary relief of nasal congestion associated with sinusitis.

    Temporarily relieves headache and sinus pain.

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  • WARNINGS

    Warnings:

    Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, if you take with other drugs containing acetaminophen (prescription or nonprescription), or if you have 3 or more alcoholic drinks every day while using this product.

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  • ASK DOCTOR

    Ask a doctor before use if you have: heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate gland, cough that occurs with too much phlegm (mucus), chronic cough that lasts such as occurs with smoking, asthma, or emphysema or chronic bronchitis.

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  • STOP USE

    Stop use and ask a doctor if: you get nervous, dizzy or sleepless, cough lasts more than 7 days, comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

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  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • OVERDOSAGE

    In case of 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.

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  • DOSAGE & ADMINISTRATION

    Directions: Do not use more than directed.

    Adults and children: (12 years and older) Take 2 tablets with water every 6 hours as needed. Do not take more than 8 tablets in 24 hours, or as directed by doctor.

    Children: (under 12 years)

    Do use unless directed by a doctor.

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  • INACTIVE INGREDIENT

    SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

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  • INGREDIENTS AND APPEARANCE
    FEDRIN 
    acetaminophen, phenylephrine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51532-0140
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    Color blue Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code FR33
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51532-0140-2 2 in 1 PACKET; Type 0: Not a Combination Product 10/25/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/25/2016
    Labeler - Afassco Inc. (609982723)
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