029 - Sed-max

029 - Sed-max
SPL v4
SPL
SPL Set ID 4920a0e9-6f88-4df0-8657-77c95a3b9617
Route
ORAL
Published
Effective Date 2017-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: AZ;029 Shape: capsule Color: red Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-11-26

Description

Acetaminophen 500mg Caffeine 65mg

Purpose

Pain reliever/fever reducer Pain reliever aid


Medication Information

Purpose

Pain reliever/fever reducer

Pain reliever aid

Description

Acetaminophen 500mg 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 caplets in 24 hours, which is the maximum daily amount

■ taken with other drugs containing acetaminophen

■ adult has 3 or more alcoholic drinks every day while using this product

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.

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.

Directions

do not use more than directed

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 of age: ask a doctor

Do Not Use

■ if you are allergic to acetaminophen

■ with other products containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Other Information

■ store at 20-25C (68-77F)

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

■you may report side effects to 1-888-952-0050

Active Ingredient(s)

Acetaminophen 500mg

Caffeine 65mg

Inactive Ingredients

corn starch, croscarmellose, 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

Sedmax
 

Stop Use and Ask A Doctor If

■ any new symptoms occur

■ painful area is red or swollen

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

These could be signs of a serious skin 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 (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.

Ask A Doctor Before Use If You Have

liver disease

Ask A Doctor Or Pharmacist Before Use If

you are taking the blood thinning drug warfarin


Structured Label Content

Uses

temporary relief of minor aches and pains due to:

■ headache

■ muscular aches

Purpose

Pain reliever/fever reducer

Pain reliever aid

Warnings

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

■ taken with other drugs containing acetaminophen

■ adult has 3 or more alcoholic drinks every day while using this product

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.

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.

Directions

do not use more than directed

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 of age: ask a doctor

Do Not Use (Do not use)

■ if you are allergic to acetaminophen

■ with other products containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Other Information (Other information)

■ store at 20-25C (68-77F)

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

■you may report side effects to 1-888-952-0050

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

Acetaminophen 500mg

Caffeine 65mg

Inactive Ingredients (Inactive ingredients)

corn starch, croscarmellose, 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

Sedmax
 

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 more than 10 days

■ fever gets worse or lasts more than 3 days

These could be signs of a serious skin condition 

Keep Out of Reach of Children (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 (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.

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

liver disease

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


Raw Label Data

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