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

Active Ingredient

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

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

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.

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

Active Ingredient (55106-9)

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

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
Other Information (Other information)
  • store between 20°-25°C (68°-77°F)
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

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.

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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