Extra Strength Headache (ld/ck)

Extra Strength Headache (ld/ck)
SPL v5
SPL
SPL Set ID d18e1631-de43-4b29-e053-2995a90af56d
Route
ORAL
Published
Effective Date 2021-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (250 mg) Caffeine (65 mg) Acetaminophen
Inactive Ingredients
Talc Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Povidone K30 Hypromellose, Unspecified Starch, Corn Stearic Acid Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S53 Shape: oval Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-24

Description

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


Medication Information

Indications and Usage

Uses

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

Directions

  • do not use more than directed (see Overdose warning)
  • 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: ask a doctor
Description

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

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking

  • any other drug containing an NSAID (prescription or nonprescription)
  • a prescription drug for diabetes, gout, or arthritis
  • any other drug or are under a doctor’s care for any serious condition
  • a blood thinning (anticoagulant) or steroid drug
Section 50569-3

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
Section 50570-1

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.
Section 51727-6

Inactive ingredients

colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone K30, pregelatinized starch, stearic acid, talc

Section 53413-1

Questions or comments?

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

Section 53414-9

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.

Section 55105-1

Purposes

Pain reliever

Pain reliever

Pain reliever aid

Section 55106-9

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Pdp (ck)

TEMPORARILY RELIEVES

HEADACHES


Compare to the active ingredients

in Excedrin ® Extra Strength*

CIRCLE K™

extra strength

headache

Acetaminophen 250 mg, Pain Reliever

Aspirin (NSAID) 250 mg, Pain Reliever

Caffeine 65 mg, Pain Reliever Aid

[caplet image]

actual size

50 caplets

Allergy Alert

Allergy alert: Aspirin may cause a severe allergic reaction,

which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
Liver Warning

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
Pdp (lil' Drug)

[caduceus]

Compare to the Active

Ingredients in Excedrin®

Extra Strength**

Extra Strength

Headache

Acetaminophen 250 mg

Pain Reliever

Aspirin (NSAID) 250 mg Pain Reliever

Caffeine 65 mg Pain Reliever Aid

[caplets image]

ACTUAL SIZE

50

Caplets [Lil' Drug Store Logo]

Reye's Syndrome

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.

Caffeine Warning

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.

Overdose Warning

Overdose warning: In case of overdose, get medical help

or contact a Poison Control Center right away

(1-800-222-1222). Quick medical attention is critical for

adults as well as for children even if you do not notice any

signs or symptoms.

Other Information
  • store between 20°-25°C (68°-77°F)
Stomach Bleeding Warning

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

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • a cold
  • arthritis
  • muscular aches
  • sinusitis
  • toothache
  • premenstrual and menstrual cramps
Dosage and Administration (34068-7)

Directions

  • do not use more than directed (see Overdose warning)
  • 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: ask a doctor
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking

  • any other drug containing an NSAID (prescription or nonprescription)
  • a prescription drug for diabetes, gout, or arthritis
  • any other drug or are under a doctor’s care for any serious condition
  • a blood thinning (anticoagulant) or steroid drug
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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.
Section 51727-6 (51727-6)

Inactive ingredients

colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone K30, pregelatinized starch, stearic acid, talc

Section 53413-1 (53413-1)

Questions or comments?

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

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Purposes

Pain reliever

Pain reliever

Pain reliever aid

Section 55106-9 (55106-9)

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Pdp (ck) (PDP (CK))

TEMPORARILY RELIEVES

HEADACHES


Compare to the active ingredients

in Excedrin ® Extra Strength*

CIRCLE K™

extra strength

headache

Acetaminophen 250 mg, Pain Reliever

Aspirin (NSAID) 250 mg, Pain Reliever

Caffeine 65 mg, Pain Reliever Aid

[caplet image]

actual size

50 caplets

Allergy Alert

Allergy alert: Aspirin may cause a severe allergic reaction,

which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
Liver Warning

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
Pdp (lil' Drug) (PDP (Lil' Drug))

[caduceus]

Compare to the Active

Ingredients in Excedrin®

Extra Strength**

Extra Strength

Headache

Acetaminophen 250 mg

Pain Reliever

Aspirin (NSAID) 250 mg Pain Reliever

Caffeine 65 mg Pain Reliever Aid

[caplets image]

ACTUAL SIZE

50

Caplets [Lil' Drug Store Logo]

Reye's Syndrome

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.

Caffeine Warning (Caffeine warning)

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.

Overdose Warning (Overdose warning)

Overdose warning: In case of overdose, get medical help

or contact a Poison Control Center right away

(1-800-222-1222). Quick medical attention is critical for

adults as well as for children even if you do not notice any

signs or symptoms.

Other Information (Other information)
  • store between 20°-25°C (68°-77°F)
Stomach Bleeding Warning (Stomach bleeding warning)

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

Advanced Ingredient Data


Raw Label Data

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