Fast Pain Relief
FDA Label NDC 70005-009

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by We Care Distributor Inc. for the product Fast Pain Relief (NDC 70005-009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(in each tablet), purpose, uses, warnings, stomach bleeding warning:, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient(In Each Tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Purpose

Pain reliever/Fever reducer


Uses

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

    • temporarily reduces fever

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:



  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters
  • If an allergic reaction occurs, stop use and seek medical help right away.


Stomach Bleeding Warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you


  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood-thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin,
    ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do Not Use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask A Doctor Before Use If

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
  • you are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are

  • under a doctor’s care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When Using This Product

  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use And Ask A Doctor If

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
      • pain gets worse or lasts more than 10 days
      • fever gets worse or lasts more than 3 days
      • redness or swelling is present in the painful area
      • any new symptoms appear

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.


Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.


Dosage & Administration

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other Information

  • each tablet contains: sodium 22 mg
  • read all warnings and directions before use
  • Keep carton or card
  • store at 20 - 25°C (68 - 77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, magnesium stearate,microcrystalline cellulose, talc, titanium dioxide


Questions Or Comments

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com


Principal Display Panel

NDC 70005-009-25

SEE NEW WARNINGS AND DIRECTIONS

We Care

For Good Health

COMPARE TO ACTIVE INGREDIENT IN Advil®* CAPLETS

TO OPEN PUSH IN TAB AND PULL OUT

Ibuprofen 200 mg

Pain Reliever/Fever Reducer (NSAID)



  • Headache
  • Toothache
  • Minor Pain of Arthritis
  • Fever
  • Muscularache
  • Menstrual Cramps
  • Ibuprofen

    *This product is not manufactured or distributed by Pfizer Healthcare, owner of the registered trademark of Advil®* tablets.

    25 Pouches of 2 Coated Tablets



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* Please review the disclaimer below.