SPL v4
SPL
SPL Set ID aa2de3a5-a20d-33c6-e053-2a95a90ada3e
Route
ORAL
Published
Effective Date 2024-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (60 mg) Pyrilamine (15 mg) Acetaminophen (500 mg)
Inactive Ingredients
Silicon Dioxide Hypromelloses Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Starch, Corn Povidone Stearic Acid Titanium Dioxide Talc

Identifiers & Packaging

Pill Appearance
Imprint: CH Shape: capsule Color: white Size: 27 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-17

Description

Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg

Purpose

Pain reliever,Diuretic, Antihistamine


Medication Information

Purpose

Pain reliever,Diuretic, Antihistamine

Description

Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg

Uses:

for the temporary relief of these symptoms associated with menstrual periods:

  • cramps
  • water-weight gain
  • headache
  • backache
  • muscle aches
  • fatigue
Pregnancy

If pregnant or breast-feeding, ask a health professional before use.

Warnings:

Liver warning:

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

  • more than 6 caplets in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert:

  • Acetaminophen may cause sever skin or sever allergy reactions. Symptoms may include:
  • skin reddening
  • blister
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock 

if a skin or general allergic reaction ocurs, stop use and seek medical help right away.

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

  • if you have ever had an allergic reaction to this product or any of its ingredients
Directions
  • do not take more than the recommended dose. adults and children 12 years of age or older
  • take 2 caplets with water
  • repeat every 6 hours, as needed
  • do not exceed 6 caplets per day
  • children under 12 years: ask a doctor

Ask Doctor:

Ask a doctor before use if you have -

  • liver disease
  • glaucoma
  • difficulty in urine due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Active Ingredient

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Other Information

store at room temperature

Inactive Ingredients

Colliodal Silicon Dioxide, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Polyvinyl Pyrrolidone, Stearaic Acid Powder, Titanium Dioxide, Talc

Ask Doctor/pharmacist:

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Questions Or Comments?

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

Principal Display Panel

When Using This Product
  • you may get drowsy
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Keep Out of Reach of Children

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.

Stope Use and Ask Doctor If 
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

Structured Label Content

Uses:

for the temporary relief of these symptoms associated with menstrual periods:

  • cramps
  • water-weight gain
  • headache
  • backache
  • muscle aches
  • fatigue
Purpose

Pain reliever,Diuretic, Antihistamine

Pregnancy (PREGNANCY)

If pregnant or breast-feeding, ask a health professional before use.

Warnings:

Liver warning:

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

  • more than 6 caplets in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert:

  • Acetaminophen may cause sever skin or sever allergy reactions. Symptoms may include:
  • skin reddening
  • blister
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock 

if a skin or general allergic reaction ocurs, stop use and seek medical help right away.

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

  • if you have ever had an allergic reaction to this product or any of its ingredients
Directions (DIRECTIONS)
  • do not take more than the recommended dose. adults and children 12 years of age or older
  • take 2 caplets with water
  • repeat every 6 hours, as needed
  • do not exceed 6 caplets per day
  • children under 12 years: ask a doctor

Ask Doctor:

Ask a doctor before use if you have -

  • liver disease
  • glaucoma
  • difficulty in urine due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Active Ingredient

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Other Information (OTHER INFORMATION)

store at room temperature

Inactive Ingredients (INACTIVE INGREDIENTS)

Colliodal Silicon Dioxide, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Polyvinyl Pyrrolidone, Stearaic Acid Powder, Titanium Dioxide, Talc

Ask Doctor/pharmacist: (ASK DOCTOR/PHARMACIST:)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this Product)
  • you may get drowsy
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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.

Stope Use and Ask Doctor If  (Stope use and Ask Doctor if )
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)