Headache Relief

Headache Relief
SPL v2
SPL
SPL Set ID 4918eb8e-be5d-40b6-88fd-a941bdc4247f
Route
ORAL
Published
Effective Date 2024-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (65 mg) Acetaminophen (250 mg) Aspirin
Inactive Ingredients
Microcrystalline Cellulose Starch, Corn Stearic Acid Silicon Dioxide Magnesium Stearate Croscarmellose Sodium Povidone K30 Sodium Starch Glycolate Type A Hypromellose, Unspecified Polyethylene Glycol, Unspecified Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: HH6 Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-10-18 Until 2026-06-30

Description

Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg

Purpose

Acetaminophen 250 mg............................................................Pain reliever Aspirin 250 mg (NSAID*)..........................................................Pain reliever Caffeine 65 mg ..................................................................Pain reliever aid (*nonsteroidal anti-inflammatory drug)


Medication Information

Purpose

Acetaminophen 250 mg............................................................Pain reliever

Aspirin 250 mg (NSAID*)..........................................................Pain reliever

Caffeine 65 mg ..................................................................Pain reliever aid

(*nonsteroidal anti-inflammatory drug)

Description

Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg

Uses:

temporarily relieves minor aches and pains due to:

•headache

•a cold

•arthritis

•muscular aches

•toothache

•premenstrual & menstrual cramps

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right

away. Quick 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 use and ask 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 for more than 10 days

■fever gets worse or lasts more than 3 days

■any new symptoms occur. These could be signs of a serious condition.

Section 51945-4

Pregnancy

If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in

pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during

delivery.

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.

Directions

■ do not use more than directed

■ drink a full glass of water with each dose

■ adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours

■ children under 12 years: ask a doctor

Ask Doctor:

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

Other Information

■ Store between 20º-25ºC (68º-77ºF)

■ Close cap tightly after use

■ Read all product information before using.

■ Keep this box for important information.

Inactive Ingredients

Microcrystalline cellulose, Pregelatinized starch, Stearic acid, Colloidal silicon dioxide, Magnesium stearate, croscarmellose sodium, PVK-K30, Sodium starch glycolate, Hydroxy propyl methyl cellulose, Polyethylene glycol, Talc, Titanium dioxide.

Ask Doctor/pharmacist:

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

Questions Or Comments?

Call +1-(732)-994-2808 or email [email protected]

Active Ingredients  (in Each Caplet)

Acetaminophen 250 mg

Aspirin 250 mg

Caffeine 65 mg


Structured Label Content

Uses:

temporarily relieves minor aches and pains due to:

•headache

•a cold

•arthritis

•muscular aches

•toothache

•premenstrual & menstrual cramps

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right

away. Quick 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 use and ask 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 for more than 10 days

■fever gets worse or lasts more than 3 days

■any new symptoms occur. These could be signs of a serious condition.

Section 51945-4 (51945-4)

Purpose

Acetaminophen 250 mg............................................................Pain reliever

Aspirin 250 mg (NSAID*)..........................................................Pain reliever

Caffeine 65 mg ..................................................................Pain reliever aid

(*nonsteroidal anti-inflammatory drug)

Pregnancy (PREGNANCY)

If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in

pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during

delivery.

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.

Directions (DIRECTIONS)

■ do not use more than directed

■ drink a full glass of water with each dose

■ adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours

■ children under 12 years: ask a doctor

Ask Doctor:

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

Other Information (OTHER INFORMATION)

■ Store between 20º-25ºC (68º-77ºF)

■ Close cap tightly after use

■ Read all product information before using.

■ Keep this box for important information.

Inactive Ingredients (INACTIVE INGREDIENTS)

Microcrystalline cellulose, Pregelatinized starch, Stearic acid, Colloidal silicon dioxide, Magnesium stearate, croscarmellose sodium, PVK-K30, Sodium starch glycolate, Hydroxy propyl methyl cellulose, Polyethylene glycol, Talc, Titanium dioxide.

Ask Doctor/pharmacist: (ASK DOCTOR/PHARMACIST:)

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

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call +1-(732)-994-2808 or email [email protected]

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

Acetaminophen 250 mg

Aspirin 250 mg

Caffeine 65 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)