Percogesic Extra Strength 63029-054

Percogesic Extra Strength 63029-054
SPL v1
SPL
SPL Set ID 2c5f1140-fb83-42c9-b0b1-5e2bd69340bb
Route
ORAL
Published
Effective Date 2024-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Diphenhydramine (12.5 mg)
Inactive Ingredients
Croscarmellose Sodium Fd&c Yellow No. 6 Hypromelloses Magnesium Stearate Microcrystalline Cellulose Mineral Oil Silicon Dioxide Sodium Starch Glycolate Type A Stearic Acid Talc Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: ES;PER Shape: capsule Color: orange Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-07-07

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Other
  • store at 15°-30°C (59°-86°F)

  • avoid excessive heat
Uses:

for temporary relief of minor aches and pains due to:

  • headache

  • backache

  • muscular aches

  • arthritis pain

  • colds

  • flu

  • fever

  • toothache

  • premenstrual and menstrual cramps

Temporarily relieves

  • runny nose

  • sneezing

  • itchy nose and throat
Section 42229-5

Drug Facts

Inactive

croscarmellose sodium, FD&C yellow no. 6 lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyvinylpyrrolidone, silica, sodium carboxymethyl starch, starch, stearic acid, talc, titanium dioxide, triacetin

Warnings

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

  • more than 6 tablets 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.

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.

Directions

Adults and children 12 years of age   and older: take 2 caplets every 6 hours. Maximum daily dose is 6 tablets. Children under 12 years of age: ask a doctor.

Do Not Use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

  • with any other product containing diphenhydramine, even one used on skin

  • If you have ever had an allergic reaction to this product or any of its ingredients
Questions?

1-800-443-4908

Principal Display Panel

EXTRA STRENGTH

Percogesic ®

Acetaminophen/


Diphenhydramine






Fever Reducer/ Antihistamine




4 0 COATED CAPLETS

When Using This Product
  • marked drowsiness may occur

  • avoid alcoholic beverages

  • alcohol, sedatives, and tranquilizers may cause drowsiness

  • may cause excitability, especially in children

  • be careful driving a motor vehicle or operating machinery.
Stop Use and Ask A Doctor If
  • pain persists for more than 10 days

  • fever persists for more than 3 days (unless directed by a doctor)

  • condition worsens or new symptoms occur

  • redness or swelling is present.

These may be signs of a serious condition.

Active Ingredient (in Each Caplet)

Acetaminophen 500 mg

Keep Out of the Reach of Children.

Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not exceed recommended dosage.

Ask A Doctor Before Use If You Have
  • liver disease

  • a breathing problem such as emphysema or chronic bronchitis

  • trouble urinating due to an enlarged prostate gland

  • glaucoma
If You Are Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Or Pharmacist Before Use If Your Are
  • taking the blood thinning drug warfarin

  • taking sedatives or tranquilizers

Structured Label Content

Other
  • store at 15°-30°C (59°-86°F)

  • avoid excessive heat
Uses:

for temporary relief of minor aches and pains due to:

  • headache

  • backache

  • muscular aches

  • arthritis pain

  • colds

  • flu

  • fever

  • toothache

  • premenstrual and menstrual cramps

Temporarily relieves

  • runny nose

  • sneezing

  • itchy nose and throat
Section 42229-5 (42229-5)

Drug Facts

Purpose

Pain reliever/fever reducer

Inactive

croscarmellose sodium, FD&C yellow no. 6 lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyvinylpyrrolidone, silica, sodium carboxymethyl starch, starch, stearic acid, talc, titanium dioxide, triacetin

Warnings

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

  • more than 6 tablets 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.

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.

Directions

Adults and children 12 years of age   and older: take 2 caplets every 6 hours. Maximum daily dose is 6 tablets. Children under 12 years of age: ask a doctor.

Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

  • with any other product containing diphenhydramine, even one used on skin

  • If you have ever had an allergic reaction to this product or any of its ingredients
Questions?

1-800-443-4908

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

EXTRA STRENGTH

Percogesic ®

Acetaminophen/


Diphenhydramine






Fever Reducer/ Antihistamine




4 0 COATED CAPLETS

When Using This Product (When using this product)
  • marked drowsiness may occur

  • avoid alcoholic beverages

  • alcohol, sedatives, and tranquilizers may cause drowsiness

  • may cause excitability, especially in children

  • be careful driving a motor vehicle or operating machinery.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain persists for more than 10 days

  • fever persists for more than 3 days (unless directed by a doctor)

  • condition worsens or new symptoms occur

  • redness or swelling is present.

These may be signs of a serious condition.

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

Acetaminophen 500 mg

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

Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not exceed recommended dosage.

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

  • a breathing problem such as emphysema or chronic bronchitis

  • trouble urinating due to an enlarged prostate gland

  • glaucoma
If You Are Pregnant Or Breast Feeding, (If you are pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Or Pharmacist Before Use If Your Are (Ask a doctor or pharmacist before use if your are)
  • taking the blood thinning drug warfarin

  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)