1. Home
  2. Labeler Index
  3. Atlantic Biologicals Corp.
  4. 17856-0376
  5. Label Information: Pharbetol

FDA Label for Pharbetol

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pharbetol Product Label

The following document was submitted to the FDA by the labeler of this product Atlantic Biologicals Corp.. 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.

Active Ingredient (In Each Tablet)



Acetaminophen 500 mg


Purpose



Pain reliever/fever reducer


Uses



  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings



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

  • more than 8 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

    • Allergy alert: 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.


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 product

Ask A Doctor Before Use If You Have



liver disease.


Ask A Doctor Or Pharmacist Before Use If You Are



taking the blood thinning drug warfarin.


Stop Use And Ask A Doctor If



  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

    • 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: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Directions



  • do not take more than directed (see overdose warning).

    • adult and children 12 years and over

    • take 2 tablets, every 4 to 6 hours while symptoms last
    • do not take more than 6 tablets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor

    children under 12 years

    Ask a doctor


Other Information



  • Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
  • store between 20-250C (68-770F)

Inactive Ingredients



povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid


Questions?



Adverse drug event call: 1-866-562-2756 Mon - Fri: 8 AM to 4 PM

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179


Package Label.Principal Display Panel



NDC 17856-0376-01

PHARBETOL

Acetaminophen 500mg

Pain Reliever • Fever Reducer

100 TABLETS

Pharbetol 500 mg Tab - 17856 0376 01

Pharbetol 500 mg Tab - 17856 0376 01


* Please review the disclaimer below.