EXTRA STRENGTH HEADACHE, LIL DRUG STORE- extra strenght headache relief- acetaminophen, aspirin, caffeine tablet tablet 
Lil' Drug Store Products, Inc.

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Headache Extra Strength, 25ct Unit Dose Box, Lil' Drug Store Products, Inc. ®

Drug Facts

​Drug Facts

Active ingredients

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin (NSAID*) 250 mg
Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

Purposes

Pain reliever

Pain reliever

Pain reliever aid

Uses

Uses

temporarily relieves minor aches and pains due to:

Warnings

Warnings

Reye’s syndrome

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

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.

Allergy alert

Allergy alert: Aspirin (NSAIDs) may cause a severe allergic reaction which may include:

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

Liver warning

Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 caplets 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

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

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 heartbeat.

Do not use

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

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

Ask a doctor or pharmacist before use if you are taking

  • a prescription drug for diabetes, gout, or arthritis
  • any other drug, or are under a doctor’s care for any serious condition

Stop use and ask a doctor if

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

These could be signs of a serious condition.

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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.

Keep out of reach of children. 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

Directions

adults and children (12 years and over)2 caplets every 6 hours as needed; not more than 8 caplets in 24 hours
children under 12 yearsask a doctor

Other information

Other information

Inactive ingredients

Inactive ingredients

colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone K30, pregelatinized starch, stearic acid, talc

Questions or comments?

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

Extra Strength Headache Relief, 25ct, Lil' Drug Store ®

Extra Strength

Headache Relief

Acetaminophen 250 mg Pain Reliever
Aspirin (NSAID*) 250 mg Pain Reliever
Caffeine 65 mg Pain Reliever Aid

[caplets image]

ACTUAL SIZE

50 CPLETS

25 POUCHES 2 CAPLETS PER POUCH

[Lil' Drug Store ® logo]

PDP/Package

EXTRA STRENGTH HEADACHE, LIL DRUG STORE 
extra strenght headache relief- acetaminophen, aspirin, caffeine tablet tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6438(NDC:68210-0107)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
POVIDONE K30 (UNII: U725QWY32X)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL ((capsule shaped, biconvex)) Size18mm
FlavorImprint Code S53
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66715-6438-625 in 1 BOX, UNIT-DOSE04/19/2022
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01304/19/2022
Labeler - Lil' Drug Store Products, Inc. (093103646)

Revised: 12/2023
Document Id: 0c41deda-490c-f5d2-e063-6394a90a5047
Set id: 0c41deda-490b-f5d2-e063-6394a90a5047
Version: 1
Effective Time: 20231211
 
Lil' Drug Store Products, Inc.