Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID b431a1a3-39c4-4d6c-afdc-c8b017ad89da
Route
ORAL
Published
Effective Date 2017-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Caffeine (65 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Croscarmellose Sodium D&c Red No. 27 Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromelloses Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: red Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-11-26

Description

Acetaminophen 500 mg Caffeine 65mg

Purpose

Pain reliever Pain reliever aid


Medication Information

Purpose

Pain reliever

Pain reliever aid

Description

Acetaminophen 500 mg Caffeine 65mg

Uses

temporary relief of 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.

Directions

Do not exceed recommended dosage.

Adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours

Children under 12 years: ask a doctor

Do Not Use

 ■ with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

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

Stop Use and Ask A Doctor If

■ any new symptoms occur    ■ symptoms do not get better or worsen    ■ 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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a PoisonControlCenter immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Ask Doctor Before Use If You Have

liver disease

Active Ingredient (in Each Caplet)

Acetaminophen 500 mg

Caffeine 65mg

Package/label Principal Display Panel

Tension Headache
Health A2Z®

*Compare to the active ingredients in Excedrin® Tension Headache

See new warnings information

TENSION HEADACHE RELIEF

Acetaminophen and Caffeine

Aspirin Free

Pain Reliever/Pain Reliever Aid

Caplets


Structured Label Content

Uses

temporary relief of 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.

Directions

Do not exceed recommended dosage.

Adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours

Children under 12 years: ask a doctor

Do Not Use

 ■ with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

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

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

■ any new symptoms occur    ■ symptoms do not get better or worsen    ■ 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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental overdose, get medical help or contact a PoisonControlCenter immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Ask Doctor Before Use If You Have (Ask doctor before use if you have)

liver disease

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Acetaminophen 500 mg

Caffeine 65mg

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Tension Headache
Health A2Z®

*Compare to the active ingredients in Excedrin® Tension Headache

See new warnings information

TENSION HEADACHE RELIEF

Acetaminophen and Caffeine

Aspirin Free

Pain Reliever/Pain Reliever Aid

Caplets


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)