Label: COLD AND SINUS PAIN RELIEF- cold and sinus pain relief 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 February 6, 2017

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

  • Active Ingredients (in each tablet) .........................................Purpose

    Acetaminophen 325 mg ........................................................................................................pain reliever/fever reducer

    Guaifenesin 200 mg .....................................................................................................................................expectorant

    Phenylephrine HCI 5 mg ...........................................................................................................................decongestant

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  • Uses:

    temporarily: ■ relieves nasal congestion associated with sinusitis ■ relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies ■ relieves sinus congestion and pressure, helps decongest sinus openings and passages ■ restores freer breathing ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive. Temporarily relieves minor aches, pains, and fever associated with: ■ headache ■ common cold ■ toothache ■ backache ■ muscular aches ■ menstrual cramps

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  • Warnings:
  • Liver Warning:

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

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  • Allergy Warning:

    acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash. If a skin reaction occurs, stop use and seek medical help right away.

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  • Do not use:

    ■ with any other product containing acetaminophen; this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. ■ for more than 10 days for pain unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor ■ when using this product do not exceed recommended dose ■ 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.

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  • Ask a doctor or pharmacist before use if:

    ■ you are taking the blood thinning drug warfarin.

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  • Stop use and ask a doctor if:

    ■ symptoms do not improve ■ pain or fever persists or gets worse ■ new symptoms occur ■ redness or swelling is present ■ nervousness, dizziness or sleeplessness occur ■ symptoms do not improve within 7 days or are accompanied by a fever • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.

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  • Ask a doctor before use if you have:

    ■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ difficulty in urination due to enlargement of the prostate gland ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)

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  • If pregnant or breast-feeding baby,

    ask a health professional before use.

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  • 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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  • Directions:

    Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.
    Children under 12 years: consult a doctor

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  • Other Information

    ■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) ■ Avoid excessive heat and humidity

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  • Inactive Ingredients:

    FD&C Red #40, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, and stearic acid

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  • INGREDIENTS AND APPEARANCE
    COLD AND SINUS PAIN RELIEF 
    cold and sinus pain relief tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71105-106
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color pink (Rose Pink) Score no score
    Shape ROUND Size 12mm
    Flavor CHERRY Imprint Code fr8
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71105-106-68 100 in 1 CARTON; Type 0: Not a Combination Product 10/01/2017
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 02/01/2017
    Labeler - Redicare LLC (800149346)
    Establishment
    Name Address ID/FEI Business Operations
    Redicare LLC 800149346 repack(71105-106)
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