Label: HISTENOL FORTE II - phenylephrine hydrochloride, acetaminophen and guaifenesin tablet

  • NDC Code(s): 35418-111-02, 35418-111-67, 35418-111-68
  • Packager: Zee Medical Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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

  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)  Acetaminophen 325 mg, Phenylephrine HCL-5 mg, Guaifenesin-100 mg

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  • PURPOSE

    Purpose-Pain reliever, Expectorant,Nasal Decongestant

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  • INDICATIONS & USAGE

    Uses ■ temporarily relieves the following cold and flu symptoms:
    ■ nasal and sinus congestion ■ headache ■ minor aches and pains
    ■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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  • DOSAGE & ADMINISTRATION

    Directions ¦ adults: take 2 tablets every 4 hours, not more than 12 tablets in 24 hours ¦ children under 12 years: ask a doctor Close
  • WARNINGS

    Warnings:Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
    ¦ more than 12 tablets in 24 hours, which is the maximum daily amount ¦ with other drugs containing acetaminophen
    ¦ 3 or more alcoholic drinks every day while using this product
    Do not use
    ¦ 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.
    ¦ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains
    acetaminophen, ask a doctor or pharmacist.
    Ask a doctor before use if you have
    ¦ heart disease ¦ high blood pressure ¦ diabetes ¦ liver disease ¦ thyroid disease
    ¦ trouble urinating due to an enlarged prostate gland
    ¦ cough that occurs with too much phlegm (mucus)
    ¦ cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
    Stop use and ask a doctor if
    ¦ you get nervous, dizzy or sleepless
    ¦ pain, nasal congestion or cough gets worse or lasts more than 7 days
    ¦ cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
    ¦ redness or swelling is present in the painful area ¦ any new symptoms appear

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  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. 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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  • INACTIVE INGREDIENT

    Inactive ingredients
    FDC red 40, maltodextrin, microcrystalline cellulose, povidone, silica, sodium starch glycolate, starch, stearic acid

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  • PRINCIPAL DISPLAY PANEL

    MM1Histenol II 250 Box 1

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  • INGREDIENTS AND APPEARANCE
    HISTENOL FORTE II 
    phenylephrine hcl, acetaminophen, guaifenesin tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:35418-111
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONE K29/32  
    SILICON DIOXIDE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STARCH, CORN  
    STEARIC ACID  
    Product Characteristics
    Color pink (rose pink) Score no score
    Shape ROUND (ZEE;HF2) Size 12mm
    Flavor Imprint Code ZEE;HF2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:35418-111-67 125 in 1 CARTON
    1 NDC:35418-111-68 50 in 1 CARTON
    1 NDC:35418-111-02 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/12/2012
    Labeler - Zee Medical Inc (009645623)
    Registrant - Ultra Seal Corporation (085752004)
    Establishment
    Name Address ID/FEI Business Operations
    Ultratab Laboratories, Inc. 151051757 manufacture(35418-111)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 repack(35418-111)
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