FDA Label for Lil Drug Store Headache Relief Extra Strength

Other

Drug Facts

Product distributed by:
Lil' Drug Store Products, Inc.
1201 Continental Place NE
Cedar Rapids, IA 52402

Otc - Purpose

Uses

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

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

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.

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 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

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 heartbeat.

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
• 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

Otc - Ask Doctor/Pharmacist

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

• 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.

  
  

Otc - Pregnancy Or Breast Feeding

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.

Otc - 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 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 caplets every 6 hours; do not take more than 8 caplets in 24 hours
• children under 12 years: do not use unless directed by a doctor

Other Information

• store between 20°-25°C (68°-77°F)

Inactive Ingredients

carnauba wax

contains one or more of these ingredients

Questions Or Comments?

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

Principal Display Panel - 50 Caplet Bottle Carton - Ndc: 66715-6822-4

QUALITY
⋆ GUARANTEED ⋆

Compare to the Active
Ingredients in Excedrin^®
Extra Strength^†

Extra Strength

Headache

Acetaminophen,
Aspirin (NSAID) and Caffeine
Pain Reliever/Pain Reliever Aid

ACTUAL SIZE

50
Caplets

Lil'
Drug Store^®

PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton - NDC: 66715-6822-4 - headache 01

Principal Display Panel - 50 Caplet Bottle Carton - Ndc: 66715-5822-4

QUALITY
⋆ GUARANTEED ⋆

Compare to the Active
Ingredients in Excedrin^®
Extra Strength^†

Extra Strength

Headache

Acetaminophen,
Aspirin (NSAID) and Caffeine
Pain Reliever/Pain Reliever Aid

ACTUAL SIZE

50
Caplets

Lil'
Drug Store^®

PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton - NDC: 66715-5822-4 - headache 02