Lil Drug Store Pain Reliever
FDA Label NDC 66715-9737

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Lil Drug Store Pain Reliever (NDC 66715-9737). 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 other, active ingredient (in each tablet), purpose, uses, liver warning, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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

Principal Display Panel (6 Tablet Pouch Carton)

Principal Display Panel (6 Tablet Pouch Carton)

* Please review the disclaimer below.