FDA Label for Lil Drug Store Pain Reliever Extra Strength

View Indications, Usage & Precautions

Lil Drug Store Pain Reliever Extra Strength Product Label

The following document was submitted to the FDA by the labeler of this product Lil Drug Store Products, 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.

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Drug Facts

Product distributed by:
Lil' Drug Store Products, Inc.
9300 Earhart Lane SW
Cedar Rapids, IA 52404


Active Ingredient (In Each Caplet)



Acetaminophen 500 mg


Purpose



Pain reliever/fever reducer


Uses



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

Liver Warning



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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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

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.


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.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



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


Directions



  • do not take more than directed (see Overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours
    • do not take for more than 10 days unless directed by a doctor
    • children under 12 years: do not use

Other Information



  • store between 68-77°F (20-25°C)

Inactive Ingredients



corn starch, croscarmellose sodium

, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, medium-chain triglycerides, mineral oil, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone, purified water, sodium starch glycolate, stearic acid, talc, titanium dioxide


Questions Or Comments?



Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)


Principal Display Panel - 500 Mg Caplet Bottle Carton



QUALITY
⋆ GUARANTEED ⋆

Compare to the
Active Ingredient in
Tylenol® Extra Strength**

Extra Strength
Pain Reliever

Acetaminophen

Pain Reliever/Fever Reducer, 500 mg

ACTUAL SIZE

50
Caplets

Lil'
Drug Store®


* Please review the disclaimer below.