Label: SINE OFF SINUS/COLD MEDICINE- acetaminophen, chlorpheniramine maleate and phenylephrine hydrochloride tablet, film coated

  • NDC Code(s): 51645-291-12, 51645-291-24
  • Packager: Gemini Pharmaceuticals, 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 07/10

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

  • Active Ingredients (in each caplet)

    Acetaminophen 500mg

    Chlorpheniramine maleate 2mg

    Phenylephrine HCl 5mg

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  • Purpose

    Pain reliever

    Antihistamine

    Nasal decongestant

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  • Uses

    • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
    • headache
    • sinus congestion and pressure
    • nasal congestion
    • runny nose and sneezing
    • minor aches and pains
    • temporarily relieves these additional symptoms of hay fever:
    • itching of the nose and throat
    • itchy, watery eyes
    • helps clear nasal passages
    • helps decongest sinus openings and passages
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  • Warnings


    Liver Warning:

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 8 caplets in 24 hours, which is maximum daily amount for this product.
    • with other drugs containing acetaminophen.
    • 3 or more alcoholic drinks every day while using this product.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are allergic to acetaminophen or any of the inactive ingredients in this products
    • if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or 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.

    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 prostrate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin.
    • taking sedatives or tranquilizers

    When using this product

    • do not exceed recommended dosage.
    • excitability may occur,especially in children
    • drowsiness may occur
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving motor vehicle or operating machinery

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • pain or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness swelling is present
    • new symptoms occur
    These  could be signs of a serious condition.

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

    Keep out of reach of children

    Overdose Warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center Right away. (1-800-222-1222). Quick 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 and older:
    • take 2 caplets every 4 to 6 hours as needed
    • Swallow whole - do not crush, chew or dissolve.
    • do not take more than 8 caplets in 24 hours.
    Children under 12 years:
    • Do not use this adult product in children under 12 years of age, this will provide more than the recommended dose (overdose) and may cause the liver damage.
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  • Other information

    • Store at room temperature
    • avoid excessive heat and humidity
    • Retain carton for complete product information
    Tamper evident: Do not use if sealed blister units are broken or damaged. Close
  • Inactive ingredients

    Croscarmellose Sodium, Crospovidone, D&C Yellow # 10, FD&C Yellow # 6, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Pregelatinized starch, Propylene glycol, Silicone dioxide, Stearic Acid, Titanium Dioxide, Triacetin.
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  • Questions or comments?

    If you have any questions or comments, or to report an adverse event, please contact 1-888-876-6898

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  • Package label Sine Off Maximum Strength

    See the New Warning Information

    Strong, Fast Relief!

    SINE®

    OFF

    SINUS/COLD MEDICINE

    • Relieves Sinus Headache
    • Pain
    • Pressure
    • Congestion
    • Runny Nose
    • Sneezing
    • Itchy, Watery eyes
    Each Caplet Contains:
    Acetaminophen 500mg.............Pain Reliever
    Chlorpheniramine maleate 2mg....Antihistamine
    Phenylephrine HCl 5mg............Nasal decongestant

    24 CAPLETS
    Sine off Sinus Cold Medicine 24 Count Label


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  • INGREDIENTS AND APPEARANCE
    SINE OFF  SINUS/COLD MEDICINE
    acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51645-291
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
    CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 2 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    CROSPOVIDONE  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    HYPROMELLOSE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONE  
    STARCH, CORN  
    PROPYLENE GLYCOL  
    SILICON DIOXIDE  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    TRIACETIN  
    Product Characteristics
    Color yellow Score no score
    Shape CAPSULE (Capsule Shaped Tablet) Size 17mm
    Flavor Imprint Code Sine;Off;PE
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51645-291-12 1 in 1 BOX
    1 12 in 1 BLISTER PACK
    2 NDC:51645-291-24 2 in 1 BOX
    2 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 07/05/2010
    Labeler - Gemini Pharmaceuticals, Inc. (055942270)
    Establishment
    Name Address ID/FEI Business Operations
    Gemini Pharmaceuticals, Inc. 055942270 manufacture
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