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 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

Warnings

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

Ask a doctor before use if you have liver disease.

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.

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

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 sodium1, hypromellose1, lactose monohydrate1, magnesium stearate1, maltodextrin1, medium-chain triglycerides1, mineral oil1, polydextrose1, polyethylene glycol1, polyvinyl alcohol1, povidone, purified water1, sodium starch glycolate1, stearic acid1, talc1, titanium dioxide

1 contains one or more of these ingredients

Questions or comments?

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

SPL UNCLASSIFIED SECTION

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

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®

INGREDIENTS AND APPEARANCE

LIL DRUG STORE PAIN RELIEVER   EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-6821(NDC:59726-494)
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)
Croscarmellose Sodium (UNII: M28OL1HH48)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Lactose Monohydrate (UNII: EWQ57Q8I5X)
Magnesium Stearate (UNII: 70097M6I30)
Maltodextrin (UNII: 7CVR7L4A2D)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Mineral Oil (UNII: T5L8T28FGP)
Polydextrose (UNII: VH2XOU12IE)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
Polyvinyl Alcohol (94000 MW) (UNII: C1MS7RRZ6L)
Povidone, Unspecified (UNII: FZ989GH94E)
Water (UNII: 059QF0KO0R)
Sodium Starch Glycolate Type A Corn (UNII: AG9B65PV6B)
Stearic Acid (UNII: 4ELV7Z65AP)
Talc (UNII: 7SEV7J4R1U)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	TCL341;AV;0821;P500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-6821-4	1 in 1 CARTON	01/17/2017
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	01/17/2017

Labeler - Lil Drug Store Products, Inc (093103646)