Midol Long Lasting Relief

Midol Long Lasting Relief
SPL v8
SPL
SPL Set ID 4a3a711d-c882-3525-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2017-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg)
Inactive Ingredients
Carnauba Wax Hypromelloses Magnesium Stearate Silicon Dioxide Croscarmellose Sodium Maltodextrin Polyethylene Glycol, Unspecified Polysorbate 80 Povidone Stearic Acid Microcrystalline Cellulose Starch, Pregelatinized Corn Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: MLLR Shape: oval Color: white Size: 18 mm Score: 1
Marketing Status
ANDA Active Since 2017-03-10
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

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

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

Allergy Alert: Acetaminophen may cuse severe skin reactions.

Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • If a skin reaction occurs, stop use and seek medical help right away.
Description

Drug Facts

Uses

Uses

  • Temporarily relieves minor aches and pains due
  • muscular aches
  • backache
  • minor pain of athritis
  • toothache
  • premenstrual and mentrual cramps
  • headache
  • the common cold
  • temporarily reduces fever
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition

Section 50568-5

As a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if you have liver disease

Section 50570-1

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 are not sure whether a drug contains acetaminophen, as a doctor or pharmacist.
  • If you are allergic to acetaminophen or any of the inactive ingredients in this product.
Section 51727-6

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycolpolysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Section 51945-4

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredients (in each caplet)

Acetaminophen 650 mg

Directions

Directions

  • do not take more than directed (see overdose warning)
adults and children 12 years and over
  • take 2 caplets every 8 hours with water
  • swallow whole; do not crush, chew, split or dissolve
  • do not take more than 6 caplets in 24 hours
    • do not use for more than 10 days unless directed by a doctor
children under 12 years
  • do not use

Other Information

Other information

  • store at 20-25° (68-77°F). Avoid excessive heat 40°C (104°F).
  • do not use if printedfoil under cap is broken or missing
Questions Or Comments

Questions or comments? 1-800-331-4536

Structured Label Content

Uses

Uses

  • Temporarily relieves minor aches and pains due
  • muscular aches
  • backache
  • minor pain of athritis
  • toothache
  • premenstrual and mentrual cramps
  • headache
  • the common cold
  • temporarily reduces fever
Warnings and Precautions (34071-1)

Warnings

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

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

Allergy Alert: Acetaminophen may cuse severe skin reactions.

Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • If a skin reaction occurs, stop use and seek medical help right away.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition

Section 50568-5 (50568-5)

As a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Section 50570-1 (50570-1)

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 are not sure whether a drug contains acetaminophen, as a doctor or pharmacist.
  • If you are allergic to acetaminophen or any of the inactive ingredients in this product.
Section 51727-6 (51727-6)

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycolpolysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredients (in each caplet)

Acetaminophen 650 mg

Directions

Directions

  • do not take more than directed (see overdose warning)
adults and children 12 years and over
  • take 2 caplets every 8 hours with water
  • swallow whole; do not crush, chew, split or dissolve
  • do not take more than 6 caplets in 24 hours
    • do not use for more than 10 days unless directed by a doctor
children under 12 years
  • do not use

Other Information (Other information)

Other information

  • store at 20-25° (68-77°F). Avoid excessive heat 40°C (104°F).
  • do not use if printedfoil under cap is broken or missing
Questions Or Comments (Questions or comments)

Questions or comments? 1-800-331-4536

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:28.133844 · Updated: 2026-03-14T23:10:57.415546