Cvs 44-390

Cvs 44-390
SPL v25
SPL
SPL Set ID 289ec101-c9a3-45f1-b2cd-8eaf8e580130
Route
ORAL
Published
Effective Date 2025-07-23
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
Starch, Corn Croscarmellose Sodium Crospovidone, Unspecified Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Povidone, Unspecified Silicon Dioxide Stearic Acid Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: 44;390 Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2002-04-29

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:

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

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

Directions
  • do not take more than directed
  • 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
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.
Other Information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • see end flap for expiration date and lot number
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
Inactive Ingredients

corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

Questions Or Comments?

1-800-426-9391

Principal Display Panel

♥CVS

actual size

Multi-Symtom

MENSTRUAL RELIEF


Acetaminophen

Caffeine | Pyrilamine Maleate

Pain reliever, Diuretic, Antihistamine

Compare to Midol® Complete

active ingredients*

Multi-Symptom Relief of: Cramps &

bloating, Fatigue, Backache & headache

24 CAPLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR

SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or

distributed by Bayer HealthCare LLC,

owner of the registered trademark

Midol® Complete.

100% money back

guaranteed.

CVS.com/returnpolicy

50844 ORG062339008

Distributed by: CVS Pharmacy, Inc., One CVS Drive

Woonsocket, RI 02895 © 2025 CVS/pharmacy

CVS.com® 1-800-SHOP CVS V-11112

CVS 44-390

When Using This Product
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • use caution when driving a motor vehicle or operating machinery 
  • 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 heart rate. The recommended dose of this product contains about as much caffeine as a cup of coffee.
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.

If Pregnant Or Breast Feeding,

ask a health professional before use. 

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.

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg 

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 bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers 

Structured Label Content

Uses

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

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

Pain reliever

Diuretic

Antihistamine

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

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

Directions
  • do not take more than directed
  • 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
Do Not Use (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.
Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • see end flap for expiration date and lot number
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
Inactive Ingredients (Inactive ingredients)

corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

♥CVS

actual size

Multi-Symtom

MENSTRUAL RELIEF


Acetaminophen

Caffeine | Pyrilamine Maleate

Pain reliever, Diuretic, Antihistamine

Compare to Midol® Complete

active ingredients*

Multi-Symptom Relief of: Cramps &

bloating, Fatigue, Backache & headache

24 CAPLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR

SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or

distributed by Bayer HealthCare LLC,

owner of the registered trademark

Midol® Complete.

100% money back

guaranteed.

CVS.com/returnpolicy

50844 ORG062339008

Distributed by: CVS Pharmacy, Inc., One CVS Drive

Woonsocket, RI 02895 © 2025 CVS/pharmacy

CVS.com® 1-800-SHOP CVS V-11112

CVS 44-390

When Using This Product (When using this product)
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • use caution when driving a motor vehicle or operating machinery 
  • 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 heart rate. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Stop Use and Ask A Doctor If (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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use. 

Keep Out of Reach of Children. (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.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg 

Ask A Doctor Before Use If You Have (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 bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers 

Advanced Ingredient Data


Raw Label Data

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