FDA Label for Pm Headache

Active Ingredients (In Each Caplet)

Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Diphenhydramine citrate 38 mg
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever
Pain reliever
Nighttime sleep-aid

Uses

for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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
• shock
• asthma (wheezing)

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• blisters
• rash
• skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

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

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

Do Not Use

• if you have ever had an allergic reaction to 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.
• with any other product containing diphenhydramine, even one used on skin
• in children under 12 years of age

Ask A Doctor Before Use If

• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have difficulty in urination due to enlargement of the prostate gland
• you have liver disease
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you have glaucoma
• you have asthma
• you have a breathing problem such as emphysema or chronic bronchitis
• you are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are Taking

• a prescription drug for diabetes, gout, or arthritis
• sedatives or tranquilizers

When Using This Product

• avoid alcoholic beverages
• drowsiness will occur
• do not drive a motor vehicle or operate machinery

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 a loss of hearing occurs
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear
  
  

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.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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
• adults and children 12 years and over: take 2 caplets at bedtime, with a full glass of water
• do not take more than 2 caplets in 24 hours, unless directed by a doctor
• children under 12 years: do not use

Other Information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive Ingredients

corn starch, crospovidone, FD&C blue #1 aluminum lake, hypromellose, maltodextrin, medium chain triglycerides, microcrystalline cellulose, polydextrose, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium sulfate, stearic acid, talc, titanium dioxide, yellow iron oxide, zinc stearate

Questions Or Comments?

1-800-426-9391

Principal Display Panel

Nighttime
Headache Relief

♥CVS™

NDC 51316-674-12

PM HEADACHE
Acetaminophen, 250 mg | Aspirin (NSAID), 250 mg
Diphenhydramine Citrate, 38 mg
Pain Reliever, Nighttime Sleep-Aid

Compare to
Excedrin® PM Headache
active ingredients^†

100 CAPLETS

Caffeine Free
Non-Habit Forming

actual size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

^†This product is not manufactured or distributed by
Haleon CH SARL, owner of the registered trademark
Excedrin® PM Headache.
50844   ORG122467412

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CVS 44-674 - cvs 44 674 pm headache 1