Equaline 44-390 Delisted

Equaline 44-390 Delisted
SPL v18
SPL
SPL Set ID 807598ef-9f03-48df-b076-3ee95ef4b06c
Route
ORAL
Published
Effective Date 2026-01-05
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 Completed Since 2002-04-29 Until 2027-02-28
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
  • water-weight gain
  • cramps
  • backache

  • fatigue
  • muscle aches 
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 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
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
Other Information
  • 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?

1-855-423-2630

Principal Display Panel

EQUALINE®   

compare to

Midol® Complete

active ingredients*

NDC 41163-390-10

maximum strength

menstrual relief

acetaminophen (pain reliever)

caffeine (diuretic)

pyrilamine maleate (antihistamine)

relieves:

• cramps, bloating, fatigue

• backache & headache

40 caplets                                    

actual size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or

distributed by Bayer HealthCare LLC, owner

of the registered trademark Midol® Complete.

50844        REV0517H39010

100% Quality

GUARANTEED

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

855-423-2630

Equaline 44-390
When Using This Product
  • avoid alcoholic beverages
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery 
  • 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.
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 accidental 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
  • water-weight gain
  • cramps
  • backache

  • fatigue
  • muscle aches 
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 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
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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Other Information (Other information)
  • 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?)

1-855-423-2630

Principal Display Panel

EQUALINE®   

compare to

Midol® Complete

active ingredients*

NDC 41163-390-10

maximum strength

menstrual relief

acetaminophen (pain reliever)

caffeine (diuretic)

pyrilamine maleate (antihistamine)

relieves:

• cramps, bloating, fatigue

• backache & headache

40 caplets                                    

actual size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or

distributed by Bayer HealthCare LLC, owner

of the registered trademark Midol® Complete.

50844        REV0517H39010

100% Quality

GUARANTEED

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

855-423-2630

Equaline 44-390
When Using This Product (When using this product)
  • avoid alcoholic beverages
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery 
  • 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.
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 accidental 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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:05.943643 · Updated: 2026-03-14T23:12:14.139281