Label: TIME-GESIC- acetaminophen and diphenhydramine hydrochloride tablet, coated

  • NDC Code(s): 49483-356-00, 49483-356-09
  • Packager: Time-Cap Labs, 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 01/14

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

  • DO NOT USE

    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.
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  • ASK DOCTOR

    Ask a doctor before use if you have liver disease.

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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers
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  • STOP USE

    Stop use and ask a doctor if

    pain persists for more than 10 days; fever persists for more than 3 days (unless directed by a doctor); condition worsens or new symptoms appear; redness or swelling is present. These could be signs of a serious condition.

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or nursing, as with any drug, seek the advise of a health professional before using this product.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of reach of children.

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  • DOSAGE & ADMINISTRATION

    Directions
    adults and children 12 years and over: take 1 to 2 tablets every six hours while symptoms last. Maximum daily dose is 9 tablets in 24 hours unless directed by a doctor.

    children under 12 years: Do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.

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  • STORAGE AND HANDLING

    Other information

    • store at 25° C (77° F) excursions permitted between 15°-30° C (59°-86° F)
    • use by expiration date on package
    • avoid excessive heat
    • sodium free
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  • INACTIVE INGREDIENT

    colloidal silicon dioxide, crospovidone, fd&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid

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  • INDICATIONS & USAGE

    Uses: temporarily releives mnor aches and pains due to:

    headache, backache, muscular aches, arthritis pain, colds, flu, fever, toothache, premenstrual cramps.

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  • PURPOSE

    Pain Reliever-fever reducer-antihistamine

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  • WARNINGS

    Warnings:

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult or child 12 years and older takes more than 12 tablets in 24 hours, which is the maximum daily amount; taking with other durgs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product.

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  • ACTIVE INGREDIENT

    Each tablet contains:

    acetaminophen 325 mg

    diphenhydramine HCl 12.5 mg

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  • INGREDIENTS AND APPEARANCE
    TIME-GESIC 
    acetaminophen and diphenhydramine hydrochloride tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49483-356
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    COLLOIDAL SILICON DIOXIDE  
    CROSPOVIDONE  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONE  
    STARCH, PREGELATINIZED CORN  
    STEARIC ACID  
    Product Characteristics
    Color orange Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code TCL106
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49483-356-09 90 in 1 BOTTLE, PLASTIC
    2 NDC:49483-356-00 100000 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 12/18/2012
    Labeler - Time-Cap Labs, Inc (037052099)
    Establishment
    Name Address ID/FEI Business Operations
    Time-Cap Labs, Inc 037052099 manufacture(49483-356)
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