Sedal 3x

Sedal 3x
SPL v3
SPL
SPL Set ID e9089f8b-3d23-5c81-e053-2995a90a4202
Route
ORAL
Published
Effective Date 2022-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Caffeine (65 mg) Aspirin
Inactive Ingredients
Microcrystalline Cellulose Sodium Starch Glycolate Type A Crospovidone Povidone Propylene Glycol Sodium Lauryl Sulfate Stearic Acid Titanium Dioxide Hypromellose, Unspecified Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: S53 Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-07

Description

Active ingredients (in each caplets) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug


Medication Information

Description

Active ingredients (in each caplets) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Uses

Uses

temporarily relieves minor aches and pains due to:

headache

a cold

arthritis

muscular aches

sinusitis

toothache

premenstrual and menstrual cramps

Section 42229-5

Manufactured in:

GMP Registered Facility in the USA



Made for:

inov FARMACEUTIQUE

Exclusively distributed by:

OPMX

Chula Vista, CA 91910

PHONE: 619-600-5632

Section 55105-1

Active ingredients

(in each caplets)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

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 tablets every 6 hours

do not take more than 8 tablets in 24 hours

children under 12 years: ask a doctor

Do Not Use

if you 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.

Allergy Alert

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

hives

shock

facial swelling

asthma (wheezing)

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take:

more than 8 tablets in 24 hours, wich is the maximum daily amount

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

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.

Overdose Warning

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.

Other Information

store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAPS IS BROKEN OR MISSING

Inactive Ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

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

Stop Use and Ask A Doctor If

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

an allergic reaction occurs. Seek medical help right away if:

any new symptoms appear

ringing in the ears or loss of hearing occurs

pain gets worse or lasts for more than 10 days

fever gets worse or lasts for more than 3 days

painful area is red or swollen

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

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 have asthma

you are taking a diuretic

Principal Display Panel 40 Caplets

NDC 69729-055-40

Sedal3x

Acetaminophen 250 mg Pain reliever

Aspirin 250 mg Pain reliever

Caffeine 65 mg Pain reliever

40 Caplets

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


Structured Label Content

Uses

Uses

temporarily relieves minor aches and pains due to:

headache

a cold

arthritis

muscular aches

sinusitis

toothache

premenstrual and menstrual cramps

Section 42229-5 (42229-5)

Manufactured in:

GMP Registered Facility in the USA



Made for:

inov FARMACEUTIQUE

Exclusively distributed by:

OPMX

Chula Vista, CA 91910

PHONE: 619-600-5632

Section 55105-1 (55105-1)

Active ingredients

(in each caplets)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

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 tablets every 6 hours

do not take more than 8 tablets in 24 hours

children under 12 years: ask a doctor

Do Not Use (Do not use)

if you 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.

Allergy Alert (Allergy alert)

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

hives

shock

facial swelling

asthma (wheezing)

Liver Warning (Liver warning)

This product contains acetaminophen. Severe liver damage may occur if you take:

more than 8 tablets in 24 hours, wich is the maximum daily amount

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Caffeine Warning (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.

Overdose Warning (Overdose warning)

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.

Other Information (Other information)

store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAPS IS BROKEN OR MISSING

Inactive Ingredients (Inactive ingredients)

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Stomach Bleeding Warning (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

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

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

an allergic reaction occurs. Seek medical help right away if:

any new symptoms appear

ringing in the ears or loss of hearing occurs

pain gets worse or lasts for more than 10 days

fever gets worse or lasts for more than 3 days

painful area is red or swollen

If Pregnant Or Breast Feeding, (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

Ask A Doctor Before Use If You Have (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 have asthma

you are taking a diuretic

Principal Display Panel 40 Caplets (PRINCIPAL DISPLAY PANEL - 40 CAPLETS)

NDC 69729-055-40

Sedal3x

Acetaminophen 250 mg Pain reliever

Aspirin 250 mg Pain reliever

Caffeine 65 mg Pain reliever

40 Caplets

Ask A Doctor Or Pharmacist Before Use If You Are Taking (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


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Raw Label Data

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