OTC Medication Information: Excedrin Extra Strength

EXCEDRIN EXTRA STRENGTH- acetaminophen, aspirin and caffeine tablet, film coated
EXCEDRIN EXTRA STRENGTH, TRAVEL BASIX- acetaminophen, aspirin and caffeine tablet, film coated
EXCEDRIN EXTRA STRENGTH, CVP HEALTH- acetaminophen, aspirin and caffeine tablet, film coated
Lil Drug Store Products, Inc

Drug Facts

Active ingredients (in each caplet) Purposes
*
nonsteroidal anti-inflammatory drug
Acetaminophen 250 mg Pain reliever
Aspirin 250 mg (NSAID *) Pain reliever
Caffeine 65 mg Pain reliever aid

Uses

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

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

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 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 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.

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

Other information

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

Inactive ingredients

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

Questions or comments?

1-800-452-0051

Packaged and distributed by Lil’ Drug Store Products, Inc.
with the permission of GSK Consumer Healthcare

Excedrin Extra Strength — 6 Caplet Pouch Carton, Lil’ Drug Store — PDP/Package

EXCEDRIN ®

EXTRA STRENGTH

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

6 Caplets 3 PACKETS OF 2 CAPLETS

Lil’
Drug Store
®

PDP
(click image for full-size original)

Excedrin Extra Strength 4ct, TRAVEL BASIX — PDP/Package

EXCEDRIN

EXTRA

STRENGTH

Acetaminophen , Aspirin (NSAID) and Caffiene

Pain Reliever / Pain Reliever Aid

[caplets image]

4

Caplets Total

(2) 2ct Packets

[TRAVEL BASIX logo]

PDP/Package
(click image for full-size original)

Excedrin Extra Strength, 4ct CVP HEALTH — PDP/Package

EXCEDRIN

EXTRA

STRENGTH

Acetaminophen, Aspirin (NSAID) and Caffiene

Pain Reliever / Pain Reliever Aid

[caplets image]

4

Caplets Total

(2) 2ct Packets

[CVP HEALTH logo]

PDP/Package
(click image for full-size original)

EXCEDRIN EXTRA STRENGTH
acetaminophen, aspirin, and caffeine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9810
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg
ASPIRIN (ASPIRIN) ASPIRIN 250 mg
CAFFEINE (CAFFEINE) CAFFEINE 65 mg
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID
CARNAUBA WAX
FD&C BLUE NO. 1
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
LIGHT MINERAL OIL
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 20
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SORBITAN MONOLAURATE
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color white (White) Score no score
Shape CAPSULE (Capsule-Shaped Tablet) Size 18mm
Flavor Imprint Code E
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66715-9810-2 2 POUCH in 1 CARTON contains a POUCH
1 2 TABLET, FILM COATED in 1 POUCH This package is contained within the CARTON (66715-9810-2)
2 NDC:66715-9810-3 3 POUCH in 1 CARTON contains a POUCH
2 2 TABLET, FILM COATED in 1 POUCH This package is contained within the CARTON (66715-9810-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 05/10/2010
EXCEDRIN EXTRA STRENGTH, TRAVEL BASIX
acetaminophen, aspirin, and caffeine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-6410
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg
ASPIRIN (ASPIRIN) ASPIRIN 250 mg
CAFFEINE (CAFFEINE) CAFFEINE 65 mg
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID
CARNAUBA WAX
FD&C BLUE NO. 1
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
LIGHT MINERAL OIL
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 20
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SORBITAN MONOLAURATE
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color white (White) Score no score
Shape CAPSULE (Capsule-Shaped Tablet) Size 18mm
Flavor Imprint Code E
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66715-6410-2 2 POUCH in 1 CARTON contains a POUCH
1 2 TABLET, FILM COATED in 1 POUCH This package is contained within the CARTON (66715-6410-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 11/28/2022
EXCEDRIN EXTRA STRENGTH, CVP HEALTH
acetaminophen, aspirin, and caffeine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-6510
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg
ASPIRIN (ASPIRIN) ASPIRIN 250 mg
CAFFEINE (CAFFEINE) CAFFEINE 65 mg
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID
CARNAUBA WAX
FD&C BLUE NO. 1
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
LIGHT MINERAL OIL
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 20
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SORBITAN MONOLAURATE
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color white (White) Score no score
Shape CAPSULE (Capsule-Shaped Tablet) Size 18mm
Flavor Imprint Code E
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66715-6510-2 2 POUCH in 1 CARTON contains a POUCH
1 2 TABLET, FILM COATED in 1 POUCH This package is contained within the CARTON (66715-6510-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 05/06/2022
Labeler — Lil Drug Store Products, Inc (093103646)

Revised: 10/2023 Lil Drug Store Products, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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