LIL DRUG STORE HEADACHE RELIEF EXTRA STRENGTH- acetaminophen, aspirin, and caffeine tablet

Lil Drug Store Headache Relief by

Drug Labeling and Warnings

Lil Drug Store Headache Relief 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

Active ingredients (in each tablet)	Purpose
* nonsteroidal anti-inflammatory drug
Acetaminophen 250 mg	Pain reliever
Aspirin 250 mg (NSAID*)	Pain reliever
Caffeine 65 mg	Pain reliever aid

Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • a cold
  • arthritis
  • muscular aches
  • sinusitis
  • toothache
  • premenstrual & menstrual cramps

Warnings

Reye's syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

• hives
• facial swelling
• asthma (wheezing)
• shock

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.

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Caffeine warning

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Do not use

• if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

• you have liver disease
• the stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have asthma

Ask a doctor or pharmacist before use if you are taking

• any other drug containing an NSAID (prescription or nonprescription)
• a blood thinning (anticoagulant) drug such as warfarin
• a steroid drug
• a prescription drug for diabetes, gout, or arthritis
• any other drug, or are under a doctor's care for any serious condition

When using this product

• take with food or milk if stomach upset occurs

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better.
• ringing in the ears or loss of hearing occurs
• painful area is red or swollen
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• any new symptoms appear

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. 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 use more than directed
• drink a full glass of water with each dose

• adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours.
• children under 12 years: ask a doctor

Other information

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

Inactive ingredients

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

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton

Compare to the Active Ingredients in
Excedrin®*

Pain Reliever/Pain Reliever Aid

Lil'
DrugStore®

Headache
Relief

EXTRA
STRENGTH

Acetaminophen, Aspirin (NSAID) and Caffeine

4 TABLETS

INGREDIENTS AND APPEARANCE

LIL DRUG STORE HEADACHE RELIEF   EXTRA STRENGTH
acetaminophen, aspirin, and caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-9738
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	250 mg
Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E)	Aspirin	250 mg
Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E)	Caffeine	65 mg

Inactive Ingredients
Ingredient Name	Strength
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)
Starch, Corn (UNII: O8232NY3SJ)
Stearic Acid (UNII: 4ELV7Z65AP)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	FR9
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-9738-2	2 in 1 CARTON	01/27/2011	09/19/2019
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 66715-9738-4	10 in 1 VIAL; Type 0: Not a Combination Product	01/27/2011	09/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075794	01/27/2011	09/12/2021

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