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  5. Label Information: Time-gesic

FDA Label for Time-gesic

View Indications, Usage & Precautions

Table of Contents

    1. OTC - DO NOT USE
    2. OTC - ASK DOCTOR
    3. OTC - ASK DOCTOR/PHARMACIST
    4. OTC - STOP USE
    5. OTC - PREGNANCY OR BREAST FEEDING
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. STORAGE AND HANDLING
    9. INACTIVE INGREDIENT
    10. INDICATIONS & USAGE
    11. OTC - PURPOSE
    12. WARNINGS
    13. OTC - ACTIVE INGREDIENT
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Time-gesic Product Label

The following document was submitted to the FDA by the labeler of this product Time-cap Labs, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - 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.

Otc - Ask Doctor



Ask a doctor before use if you have liver disease.


Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are

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

Otc - 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.


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep this and all drugs out of reach of children.


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.


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

Inactive Ingredient



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


Indications & Usage



Uses: temporarily releives mnor aches and pains due to:

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


Otc - Purpose



Pain Reliever-fever reducer-antihistamine


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.


Otc - Active Ingredient



Each tablet contains:

acetaminophen 325 mg

diphenhydramine HCl 12.5 mg


Package Label.Principal Display Panel



356R LABEL - 356Rlabel

356R LABEL - 356Rlabel


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