FDA Label for Excedrin Pm Triple Action Caplets And Excedrin Extra Strength Pain Reliever

View Indications, Usage & Precautions

Excedrin Pm Triple Action Caplets And Excedrin Extra Strength Pain Reliever Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Excedrin Pm Headache

[Enter Generic Section here]

Active Ingredients (In Each Caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Diphenhydramine citrate 38 mg

*nonsteroidal anti-inflammatory drug

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Nighttime sleep-aid

Pain reliever

Pain reliever aid

Uses

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

•temporarily relieves minor aches and pains due to:
- oheadache
- oa cold
- oarthritis
- omuscular aches
- otoothache
- opremenstrual & 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: 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: 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 2 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

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: 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 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.
•with any other product containing diphenhydramine, even one used on skin
•in children under 12 years of age

•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
•you have glaucoma
•you have a breathing problem such as emphysema or chronic bronchitis
•you have trouble urinating due to an enlarged prostate gland

•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

Ask A Doctor Or Pharmacist Before Use If You Are

taking

•a prescription drug for:
- •diabetes
- •gout
- •arthritis
- •any other drug, or are under a doctor’s care for any serious condition
- •any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
- •sedatives or tranquilizers

When Using This Product

•drowsiness will occur
•avoid alcoholic drinks
•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
- •sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- •pain gets worse or last for more than 10 days
- •painful area is red or swollen
- •ringing in the ears or a loss of hearing occurs
- •any new symptoms occur

If Pregnant Or Breast-Feeding,

ask a health professional before use. It is especially important not to use aspirin during the last three 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
•do not use in children under 12 years of age
•adults and children 12 years of age 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

•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; not more than 8 caplets in 24 hours
•children under 12 years: ask a doctor

Other Information

•store at 20°-25°C (68°-77°F).
•close cap tightly after use.
•read all product information before using. Keep this box for important information.

•store at 20°-25°C (68°-77°F)
•close cap tightly after use
•read all product information before using. Keep this box for important information.

Inactive Ingredients

benzoic acid, calcium carbonate, FD&C blue#1 aluminum lake, hydroxypropyl cellulose low substituted, hypromellose, magnesium stearate, maltodextrin, medium-chain triglycerides, polydextrose, polysorbate 80, povidone, pregelatinized corn starch, silicified microcrystalline cellulose, stearic acid, talc, titanium dioxide, yellow iron oxide, zinc stearate

benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Questions Or Comments?

1-800-452-0051

Excedrin Extra Strength

[Enter Generic Section here]

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

Principal Display Panel (Excedrin Pm Headache)

DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME. USE PRODUCTS AS DIRECTED.

NDC 0067-2056-24

EXCEDRIN_®

PM HEADACHE

Acetaminophen, Aspirin (NSAID) and Diphenhydramine Citrate

Pain Reliever/Nighttime Sleep-Aid

Triple Action Formula

Caffeine-Free

Non-Habit Forming

24 CAPLETS

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059

Visit us at www.excedrin.com

46172695

Excedrin PM 24 count carton - image 01

Principal Display Panel (Excedrin Extra Strength)

NDC 0067-2000-91