Menstrual Pain Relief Complete

Menstrual Pain Relief Complete
SPL v3
SPL
SPL Set ID 5efd6c61-74ed-4253-896a-e4a40bd8f25b
Route
ORAL
Published
Effective Date 2025-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Caffeine (60 mg) Pyrilamine (15 mg)
Inactive Ingredients
Calcium Phosphate Croscarmellose Sodium Fd&c Yellow No. 6 Hypromelloses Isopropyl Alcohol Magnesium Stearate Methylene Chloride Microcrystalline Cellulose Starch, Corn Pyrrolidone Sodium Starch Glycolate Type A Povidone Stearic Acid Talc Titanium Dioxide Polyethylene Glycol 400 Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: SD33 Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-07

Description

Drug Facts

Purpose

Pain reliever Diuretic Antihistamine


Medication Information

Purpose

Pain reliever

Diuretic

Antihistamine

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a 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

These could be signs of a serious condition.

Section 50567-7

When using this product

  • avoid alcoholic beverages
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machiner
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • you may get drowsy
  • 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. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Section 50568-5

Ask a doctor or pharmacist before use if youare

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3

Ask a doctor before use if you have

  • difficulty in urination due to enlargement of the prostate gland
  • liver disease _ glaucoma
  • a breathing problem such as emphysema or chronic
Section 50570-1

Do not use

  • if you have ever had an allergic reaction to this product or any of its ingredients
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Section 53414-9

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

uses

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

  • cramps
  • bloating
  • water
  • weight gain
  • headache
  • backache
  • muscle aches
  • fatigue
Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

If a skin reaction occurs, stop use and seek medical help right away.

Directions

adults and children 12 years and over:

  • do not take more than the recommended dose
  • adults and children 12 years and over: 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
Other Information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
Inactive Ingredients

aerosil, calcium phosphate, colloidal silicon dioxide, cross carmellose sodium, FD&C yellow #6, hypromellose, isopropyl alcohol, magnesium stearate, methlyene chloride, microcrystalline cellulose, pregelatinized starch, polyethylene glycols, poly vinyl pyrrolidone, povidone, sodium starch glycolate*, stearic acid, talc, titanium dioxide

*may contain these ingredients

Questions Or Comments?

1-800-373-6981 (toll-free)

Principal Display Panel

Menstrual Pain Relief Complete



Acetaminophen/Caffeine/Pyrilamine maleate

Pain reliever/Diuretic/Antihistamine

Label

Carton

Active Ingredient (in Each Liquid Filled Capsule)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg


Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a 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

These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product

  • avoid alcoholic beverages
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machiner
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • you may get drowsy
  • 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. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if youare

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • difficulty in urination due to enlargement of the prostate gland
  • liver disease _ glaucoma
  • a breathing problem such as emphysema or chronic
Section 50570-1 (50570-1)

Do not use

  • if you have ever had an allergic reaction to this product or any of its ingredients
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Section 53414-9 (53414-9)

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

Purpose

Pain reliever

Diuretic

Antihistamine

uses (Uses)

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

  • cramps
  • bloating
  • water
  • weight gain
  • headache
  • backache
  • muscle aches
  • fatigue
Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

If a skin reaction occurs, stop use and seek medical help right away.

Directions

adults and children 12 years and over:

  • do not take more than the recommended dose
  • adults and children 12 years and over: 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
Other Information (Other information)
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
Inactive Ingredients (Inactive ingredients)

aerosil, calcium phosphate, colloidal silicon dioxide, cross carmellose sodium, FD&C yellow #6, hypromellose, isopropyl alcohol, magnesium stearate, methlyene chloride, microcrystalline cellulose, pregelatinized starch, polyethylene glycols, poly vinyl pyrrolidone, povidone, sodium starch glycolate*, stearic acid, talc, titanium dioxide

*may contain these ingredients

Questions Or Comments? (Questions or comments?)

1-800-373-6981 (toll-free)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Menstrual Pain Relief Complete



Acetaminophen/Caffeine/Pyrilamine maleate

Pain reliever/Diuretic/Antihistamine

Label

Carton

Active Ingredient (in Each Liquid Filled Capsule) (Active ingredient (in each liquid-filled capsule))

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)