Percogesic Original 63029-053

Percogesic Original 63029-053
SPL v2
SPL
SPL Set ID 529974c2-0121-4892-8e47-c2c447581091
Route
ORAL
Published
Effective Date 2025-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Diphenhydramine (12.5 mg)
Inactive Ingredients
Croscarmellose Sodium Fd&c Yellow No. 6 Hypromellose, Unspecified Talc Cellulose, Microcrystalline Light Mineral Oil Polyethylene Glycol 400 Silicon Dioxide Stearic Acid Sodium Starch Glycolate Type A Potato Starch, Corn Povidone K30

Identifiers & Packaging

Pill Appearance
Imprint: Percogesic Shape: round Color: orange Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-03-19 Until 2022-06-27

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

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

Overdose

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.

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 

  • 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

Do not exceed recommended dosage. Adults and children 12 years and   older: take 2 tablets every 4-6 hours. Maximum daily dose is 8 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

Other Information
  • store at controlled room temperature 15°-30°C (59°-86°F)  

  • avoid excessive heat
Inactive Ingredients

Croscarmellose Sodium, FD&C Yellow #6 Lake, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Pregelatinized Starch, Silica, Sodium Starch Glycolate and Stearic Acid

Principal Display Panel

ORIGINAL STRENGTH

Percogesic ®

Acetaminophen/Diphenhydramine
HCl



Aspirin-Free, Pain Reliever,


Fever Reducer/ Antihistamine




5 0 COATED TABLETS

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 Ingredients (in Each Tablet)

Acetaminophen 325 mg

Ask A Doctor Or Pharmacist Before Use
  • liver disease

  • a breathing problem such as emphysema or chronic bronchitis

  • trouble urinating due to an enlarged prostate gland

  • glaucoma

Structured Label Content

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

Overdose

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.

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 

  • 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

Do not exceed recommended dosage. Adults and children 12 years and   older: take 2 tablets every 4-6 hours. Maximum daily dose is 8 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

Other Information
  • store at controlled room temperature 15°-30°C (59°-86°F)  

  • avoid excessive heat
Inactive Ingredients

Croscarmellose Sodium, FD&C Yellow #6 Lake, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Pregelatinized Starch, Silica, Sodium Starch Glycolate and Stearic Acid

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ORIGINAL STRENGTH

Percogesic ®

Acetaminophen/Diphenhydramine
HCl



Aspirin-Free, Pain Reliever,


Fever Reducer/ Antihistamine




5 0 COATED TABLETS

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 Ingredients (in Each Tablet) (Active Ingredients (in each tablet))

Acetaminophen 325 mg

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)
  • liver disease

  • a breathing problem such as emphysema or chronic bronchitis

  • trouble urinating due to an enlarged prostate gland

  • glaucoma

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)