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


Active Ingredient (In Each Tablet)



Acetaminophen 500 mg


Purpose



Pain reliever/fever reducer


Uses



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

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.

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

Otc - Stop Use



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. 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 tablets every 4 to 6 hours while symptoms last
    • do not take more than 8 tablets in 24 hours
    • do not use for more than 10 days unless directed by a doctor
    children under 12 years of age
    • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other Information



  • do not use if inner pouch or carton is open or damaged
  • store at room temperature 59-86°F (15-30°C)
  • see bottom panel for lot number and expiration date

Inactive Ingredients



corn starch, hypromellose, maltodextrin

may contain

, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide


Questions Or Comments?



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


Principal Display Panel - 6 Tablet Pouch Carton



Compare to the Active Ingredient in
Tylenol® Extra Strength*

EXTRA STRENGTH

Lil'
DrugStore®

Pain Reliever
ACETAMINOPHEN
Pain Reliever / Fever Reducer, 500 mg

6 TABLETS


* Please review the disclaimer below.