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  5. Label Information: Flaxendol Extra Strength Acetaminophen

FDA Label for Flaxendol Extra Strength Acetaminophen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SOFTGEL CAPSULE)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE
    7. ASK A DOCTOR OR PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. STOP USING AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PACKAGE LABELING:

Flaxendol Extra Strength Acetaminophen Product Label

The following document was submitted to the FDA by the labeler of this product Gelpharma S.a. De C.v.. 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 Softgel Capsule)



Acetaminophen 500 mg


Purpose



Pain reliever/fever reducer


Uses



for the temporary relief of minor aches and pains associated with

  • the common cold
  • headache
  • toothache
  • muscular aches
  • backache
  • premenstrual and menstrual
  • the minor pain from arthritis
  • to reduce fever

Warnings



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

more than 8 softgel capsules 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.

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.


When Using This Product



  • do not exceed recommended dosage
  • do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. If pain or fever persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.
  • if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor

Stop Using And Ask A Doctor If



  • pain gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

If Pregnant Or Breast-Feeding,



ask a health professional before use.


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 children even if you do not notice any signs or symptoms Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



  • Adults and children 12 years and over: Take 2 capsules every 6 hours while symptoms last. Do not take more than 6 capsules in 24 hours unless directed by a doctor.
  • Children under 12 years of age: consult a doctor.

Other Information



  • Store at 68-77°F (20-25°C)
  • Avoid high humidity

Inactive Ingredients



FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, silicon dioxide, titanium dioxide, water


Questions Or Comments?



(346) 326-1728 Mon-Fri 8:00a.m. EST to 5:00p.m. EST


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