Dollar General 44-390 Maximum Strength-delisted

Dollar General 44-390 Maximum Strength-delisted
SPL v14
SPL
SPL Set ID 573985d2-1b2b-45ed-a729-80522177c63e
Route
ORAL
Published
Effective Date 2024-10-03
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 2026-03-05

Description

Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg


Medication Information

Warnings and Precautions

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.

Indications and Usage

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

  • bloating
  • headache
  • water-weight gain
  • cramps
  • backache
  • fatigue
  • muscle aches
Dosage and Administration
  • 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
Description

Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg

Section 44425-7
  • see end flap for expiration date and lot number
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
Section 50565-1

In case of accidental 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.

Section 50566-9
  • 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
  • avoid alcoholic beverages
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • 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
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3
  • difficulty in urination due to enlargement of the prostate gland
  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
Section 50570-1
  • 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
Section 51727-6

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

Section 51945-4

DG ™ | health

Compare to active

ingredients of

Midol® Complete*

Maximum Strength

Menstrual Relief

Acetaminophen
• Caffeine • Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

Multi-Symptom Relief of:

• Cramps   • Bloating

• Fatigue    • Backache

• Headache

40 Caplets

Actual Caplet 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

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction

Guaranteed!


(888) 309-9030

DG Health 44-390
Section 53413-1

1-888-309-9030

Section 53414-9

ask a health professional before use.

Section 55105-1

Pain reliever

Diuretic

Antihistamine

Section 55106-9

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg


Structured Label Content

Indications and Usage (34067-9)

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

  • bloating
  • headache
  • water-weight gain
  • cramps
  • backache
  • fatigue
  • muscle aches
Dosage and Administration (34068-7)
  • 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
Warnings and Precautions (34071-1)

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.

Section 44425-7 (44425-7)
  • see end flap for expiration date and lot number
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
Section 50565-1 (50565-1)

In case of accidental 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.

Section 50566-9 (50566-9)
  • 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)
  • avoid alcoholic beverages
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • 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)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3 (50569-3)
  • difficulty in urination due to enlargement of the prostate gland
  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
Section 50570-1 (50570-1)
  • 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
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

DG ™ | health

Compare to active

ingredients of

Midol® Complete*

Maximum Strength

Menstrual Relief

Acetaminophen
• Caffeine • Pyrilamine Maleate

Pain Reliever/Diuretic/Antihistamine

Multi-Symptom Relief of:

• Cramps   • Bloating

• Fatigue    • Backache

• Headache

40 Caplets

Actual Caplet 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

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction

Guaranteed!


(888) 309-9030

DG Health 44-390
Section 53413-1 (53413-1)

1-888-309-9030

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Pain reliever

Diuretic

Antihistamine

Section 55106-9 (55106-9)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg


Advanced Ingredient Data


Raw Label Data

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