Greenfield - Tension Headache

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Caffeine (65 mg)

Inactive Ingredients

Starch, Corn Croscarmellose Sodium Crospovidone D&c Red No. 27 Aluminum Lake Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromellose, Unspecified Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone Silicon Dioxide Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: AZ029 Shape: capsule Color: red Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-11-22

Medication Information

Purpose

Pain reliever

Pain reliever aid

Description

Acetaminophen 500 mg Caffeine 65mg

Use(s)

temporarily relieves minor aches and pains due to:

headache

muscular aches

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you ■ take more than 8 tablets in 24 hours, which is the maximum daily amount ■ take with other drugs containing acetaminophen ■ have 3 or more alcoholic drinks every day while using this product

Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock

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.

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.

Questions

1-888-952-0050 (Monday through Friday 9AM - 5PM EST

Directions

Do not use more than directed

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

Do Not Use

if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains

acetaminophen, ask a doctor or pharmacist.

Other Information

Store at 20-25°C (68-77° F)

Do not use if imprinted safety seal under cap is broken or missing

Active Ingredient(s)

Acetaminophen 500 mg

Caffeine 65mg

Inactive Ingredients

corn starch, croscarmellose sodium, crospovidone, D&C red #27 aluminum lake, FD&C red #40

aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone,

pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Pregnancy/breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Principal Display Panel

Tension Headache

Ask A Doctor Before Use If

you have liver disease

Stop Use and Ask A Doctor If

any new symptoms occur
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

These could be signs of a serious condition.

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.

Ask A Doctor Or Pharmacist Before Use If

you are taking the blood thinning drug warfarin

Structured Label Content

Use(s)

temporarily relieves minor aches and pains due to:

headache

muscular aches

Purpose

Pain reliever

Pain reliever aid

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you ■ take more than 8 tablets in 24 hours, which is the maximum daily amount ■ take with other drugs containing acetaminophen ■ have 3 or more alcoholic drinks every day while using this product

Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock

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.

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.

Questions

1-888-952-0050 (Monday through Friday 9AM - 5PM EST

Directions

Do not use more than directed

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

Do Not Use (Do not use)

if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains

acetaminophen, ask a doctor or pharmacist.

Other Information (Other information)

Store at 20-25°C (68-77° F)

Do not use if imprinted safety seal under cap is broken or missing

Active Ingredient(s) (Active ingredient(s))

Acetaminophen 500 mg

Caffeine 65mg

Inactive Ingredients (Inactive ingredients)

corn starch, croscarmellose sodium, crospovidone, D&C red #27 aluminum lake, FD&C red #40

aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone,

pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

If pregnant or breast-feeding, ask a health professional before use.

Principal Display Panel

Tension Headache

Ask A Doctor Before Use If (Ask a doctor before use if)

you have liver disease

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

any new symptoms occur
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

These could be signs of a serious condition.

Keep Out of Reach of Children (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.

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

you are taking the blood thinning drug warfarin

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use(s)": "temporarily relieves minor aches and pains due to: headache muscular aches", "Purpose": "Pain reliever Pain reliever aid", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you ■ take more than 8 tablets in 24 hours, which is the maximum daily amount ■ take with other drugs containing acetaminophen ■ have 3 or more alcoholic drinks every day while using this product Allergy alert : Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock 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. 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.", "Questions": "1-888-952-0050 (Monday through Friday 9AM - 5PM EST", "Directions": "Do not use more than directed 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", "Do not use": "if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.", "Other information": "Store at 20-25°C (68-77° F) Do not use if imprinted safety seal under cap is broken or missing", "Active ingredient(s)": "Acetaminophen 500 mg Caffeine 65mg", "Inactive ingredients": "corn starch, croscarmellose sodium, crospovidone, D&C red #27 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide", "Pregnancy/Breastfeeding": "If pregnant or breast-feeding, ask a health professional before use.", "Principal Display Panel": "Tension Headache Tension Headache", "Ask a doctor before use if": "you have liver disease", "Stop use and ask a doctor if": "any new symptoms occur 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 These could be signs of a serious condition.", "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.", "Ask a doctor or pharmacist before use if": "you are taking the blood thinning drug warfarin"}

Greenfield - Tension Headache

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information