347r Target Menstrual Relief Caplets

347r Target Menstrual Relief Caplets
SPL v2
SPL
SPL Set ID 2368ac1b-d644-9908-e063-6394a90a4b89
Route
ORAL
Published
Effective Date 2025-01-29
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
Hypromellose, Unspecified Silicon Dioxide Titanium Dioxide Starch, Corn Crospovidone, Unspecified Microcrystalline Cellulose Stearic Acid Croscarmellose Sodium Magnesium Stearate Mineral Oil Povidone

Identifiers & Packaging

Pill Appearance
Imprint: TCL347 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-07

Description

Active ingredients (in each caplet) Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg


Medication Information

Warnings and Precautions

Warnings

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

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

Allergy alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

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

Indications and Usage

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

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

Directions

  • do not take more than the recommended dose
  • adults and children 12 years and older: take 2 caplets with water. Repeat every 6 hours, as needed. Do not exceed 6 caplets per day
  • children under 12 years: consult a doctor
Description

Active ingredients (in each caplet) Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg

Section 50565-1

Keep out of reach of children. 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

  • 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
Section 50567-7

When using this product

  • you may get drowsy
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • limit the use of caffeine-containing medications, foods, or beverages 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 you are

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

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
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 have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid, titanium dioxide

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-877-290-4008

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever

Diuretic

Antihistamine

Section 55106-9

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Section 60561-8

Other information

  • Store at room temperature. Avoid excessive heat above 40°C (104°F).

Structured Label Content

Indications and Usage (34067-9)

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

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

Directions

  • do not take more than the recommended dose
  • adults and children 12 years and older: take 2 caplets with water. Repeat every 6 hours, as needed. Do not exceed 6 caplets per day
  • children under 12 years: consult a doctor
Warnings and Precautions (34071-1)

Warnings

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

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

Allergy alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

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

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 (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

  • 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
Section 50567-7 (50567-7)

When using this product

  • you may get drowsy
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • limit the use of caffeine-containing medications, foods, or beverages 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 you are

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

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
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 have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6 (51727-6)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-877-290-4008

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever

Diuretic

Antihistamine

Section 55106-9 (55106-9)

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Section 60561-8 (60561-8)

Other information

  • Store at room temperature. Avoid excessive heat above 40°C (104°F).

Advanced Ingredient Data


Raw Label Data

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