LIL DRUG STORE PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet

Lil Drug Store Pain Reliever by

Drug Labeling and Warnings

Lil Drug Store Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. 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

Ask a doctor before use if you have liver disease

Ask a doctor 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.

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

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 6 hours while symptoms last
  • do not take more than 6 tablets in 24 hours unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
• children under 12 years: ask a doctor

Other information

• do not use if vial is open or damaged or safety seal has been removed
• store at room temperature 59-86°F (15-30°C)

Inactive ingredients

corn starch, hypromellose, maltodextrin1, microcrystalline cellulose1, polyethylene glycol, povidone1, pregelatinized starch1, sodium starch glycolate1, stearic acid, titanium dioxide1

1 may contain

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 10 Tablet Vial Label

★ QUALITY GUARANTEED ★

Compare to the Active Ingredient
in Tylenol® Extra Strength*

Extra Strength
Pain Reliever

Acetaminophen, 500 mg
Pain Reliever/Fever Reducer

10
Tablets

Lil'
DrugStore®

OPEN HERE FOR DRUG FACTS INFORMATION

INGREDIENTS AND APPEARANCE

LIL DRUG STORE PAIN RELIEVER   EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-9737
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	500 mg

Inactive Ingredients
Ingredient Name	Strength
Starch, Corn (UNII: O8232NY3SJ)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Maltodextrin (UNII: 7CVR7L4A2D)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
Povidone, Unspecified (UNII: FZ989GH94E)
Sodium Starch Glycolate Type A Corn (UNII: AG9B65PV6B)
Stearic Acid (UNII: 4ELV7Z65AP)
Titanium Dioxide (UNII: 15FIX9V2JP)
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR33
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-9737-3	3 in 1 CARTON	01/27/2011	08/30/2021
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 66715-9737-4	10 in 1 VIAL; Type 0: Not a Combination Product	01/27/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	01/27/2011

Labeler - Lil' Drug Store Products, Inc. (093103646)