370r Headache Relief Caplets Kroger 41226 370

370r Headache Relief Caplets Kroger 41226 370
SPL v4
SPL
SPL Set ID bbed29a1-3c52-3531-e053-2995a90a686c
Route
ORAL
Published
Effective Date 2021-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (65 mg) Aspirin (250 mg) Acetaminophen
Inactive Ingredients
Titanium Dioxide Cellulose, Microcrystalline Silicon Dioxide Hypromelloses Stearic Acid Starch, Corn Povidone Mineral Oil Sodium Starch Glycolate Type A Corn Carnauba Wax

Identifiers & Packaging

Pill Appearance
Imprint: TCL;370 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-10

Description

ACETAMINOPHEN/ ASPIRIN (NSAID)/ CAFFEINE


Medication Information

Warnings and Precautions

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: Aspirin may cause a severe allergic reaction, which may include:

•hives

•facial swelling

•shock

•asthma (wheezing)

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.



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 heartbeat.

Indications and Usage

Uses

temporarily relieves minor aches and pains due to:

•headache

•a cold

•arthritis

•muscular aches

•toothache

•premenstrual and menstrual cramps

Dosage and Administration

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

•children under 12 years: ask a doctor

Description

ACETAMINOPHEN/ ASPIRIN (NSAID)/ CAFFEINE

Section 50565-1

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop using and ask a doctor if

•symptoms do not improve

•new symptoms occur

•pain or fever persists or gets worse

•you experience any of the following signs of stomach bleeding:

feel faint

have bloody or black stools

vomit blood

have stomach pain that does not get better

•ringing in the ears or loss of hearing occurs, consult a doctor before taking any more of this product.

Section 50568-5

Ask a doctor or pharmacist before use if you are

•taking a prescription drug for diabetes, gout, or arthritis

•taking any other drug or are under a doctor’s care for any serious condition

Section 50569-3

Ask a doctor before use if

•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

Section 50570-1

Do not use

•with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

•for more than 10 days for pain unless directed by a doctor

•for more than 3 days for fever unless directed by a doctor

Section 51727-6

Inactive ingredients

carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, pregelatinized starch, povidone, sodium starch glycolate, stearic acid, titanium dioxide

Section 51945-4

Section 53413-1

Questions or comments?

call 1-800-632-6900

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

Pain reliever/Pain reliever aid

Section 55106-9

Active ingredient (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Drug Facts

ACETAMINOPHEN/ ASPIRIN (NSAID)/ CAFFEINE

Other Information

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves minor aches and pains due to:

•headache

•a cold

•arthritis

•muscular aches

•toothache

•premenstrual and menstrual cramps

Dosage and Administration (34068-7)

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

•children under 12 years: ask a doctor

Warnings and Precautions (34071-1)

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: Aspirin may cause a severe allergic reaction, which may include:

•hives

•facial swelling

•shock

•asthma (wheezing)

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.



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 heartbeat.

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop using and ask a doctor if

•symptoms do not improve

•new symptoms occur

•pain or fever persists or gets worse

•you experience any of the following signs of stomach bleeding:

feel faint

have bloody or black stools

vomit blood

have stomach pain that does not get better

•ringing in the ears or loss of hearing occurs, consult a doctor before taking any more of this product.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

•taking a prescription drug for diabetes, gout, or arthritis

•taking any other drug or are under a doctor’s care for any serious condition

Section 50569-3 (50569-3)

Ask a doctor before use if

•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

Section 50570-1 (50570-1)

Do not use

•with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

•for more than 10 days for pain unless directed by a doctor

•for more than 3 days for fever unless directed by a doctor

Section 51727-6 (51727-6)

Inactive ingredients

carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, pregelatinized starch, povidone, sodium starch glycolate, stearic acid, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

call 1-800-632-6900

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)

Pain reliever/Pain reliever aid

Section 55106-9 (55106-9)

Active ingredient (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Drug Facts (DRUG FACTS)

ACETAMINOPHEN/ ASPIRIN (NSAID)/ CAFFEINE

Other Information (OTHER INFORMATION)

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)