Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 444fa225-c204-45d1-b3b3-aa5650ee5d07
Route
ORAL
Published
Effective Date 2023-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Aspirin (38 mg) Diphenhydramine (65 mg) Caffeine
Inactive Ingredients
Benzoic Acid Calcium Carbonate Fd&c Blue No. 1 Low-substituted Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Magnesium Stearate Maltodextrin Medium-chain Triglycerides Polydextrose Polysorbate 80 Povidone, Unspecified Starch, Corn Microcrystalline Cellulose Stearic Acid Talc Titanium Dioxide Ferric Oxide Yellow Zinc Stearate Carnauba Wax Hydroxypropyl Cellulose, Unspecified Light Mineral Oil Polysorbate 20 Propylene Glycol Dimethicone, Unspecified Sorbitan Monolaurate

Identifiers & Packaging

Pill Appearance
Imprint: E Shape: rectangle Shape: capsule Color: blue Color: white Size: 17 mm Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-05-01

Description

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

Purpose

Pain reliever Pain reliever Nighttime sleep-aid


Medication Information

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Description

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

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

Pain reliever

Pain reliever

Nighttime sleep-aid

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
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
  • 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
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.
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

Questions Or Comments?

1-800-452-0051

Excedrin Extra Strength

[Enter Generic Section here]

When Using This Product
  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery
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
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

These could be signs of a serious condition

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.

Active Ingredients (in Each Caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Diphenhydramine citrate 38 mg

*nonsteroidal anti-inflammatory drug

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

©2015 GSK or its licensor.

Visit us at www.excedrin.com

46172695

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
Principal Display Panel (excedrin Extra Strength)

NDC 0067-2000-91

EXCEDRIN ®

EXTRA STRENGTH

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever / Pain Reliever Aid

100 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

©2015 GSK group of companies or its licensor. All rights reserved.

Visit us at www.excedrin.com

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

46172044

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

Structured Label Content

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

Pain reliever

Pain reliever

Pain reliever aid

Purposes

Pain reliever

Pain reliever

Nighttime sleep-aid

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
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 (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
Other Information (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.
Inactive Ingredients (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

Questions Or Comments? (Questions or comments?)

1-800-452-0051

Excedrin Extra Strength

[Enter Generic Section here]

When Using This Product (When using this product)
  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery
Ask A Doctor Before Use If (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
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
  • 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

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 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. (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.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Diphenhydramine citrate 38 mg

*nonsteroidal anti-inflammatory drug

Principal Display Panel (excedrin Pm Headache) (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

©2015 GSK or its licensor.

Visit us at www.excedrin.com

46172695

Ask A Doctor Or Pharmacist Before Use If You Are (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
Principal Display Panel (excedrin Extra Strength) (Principal Display Panel (Excedrin Extra Strength))

NDC 0067-2000-91

EXCEDRIN ®

EXTRA STRENGTH

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever / Pain Reliever Aid

100 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

©2015 GSK group of companies or its licensor. All rights reserved.

Visit us at www.excedrin.com

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

46172044

Ask A Doctor Or Pharmacist Before Use If You Are Taking (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

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