Cramp Tabs Capsule, Coated
FDA Label NDC 73598-1472

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jhk Dba American Safety & First Aid for the product Cramp Tabs (NDC 73598-1472). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, use, liver warning, allergy alert, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Otc - Purpose

Active ingredient (In Each Caplet)Purpose
Acetaminophen 500mgpain reliever/fever reducer
Pamabrom 25mgdiuretic
Pyrilamine maleate 15 mgAntihistamine

Use

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

  • headache
  • bloating
  • cramps
  • backache
  • muscular aches
  • muscular aches
  • irritability
  • water-weight gain

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.

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

Ask A Doctor Before Use If You Have

  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • liver disease
  • glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When Using This Product

  • drowsiness may occur
  • avoid alcoholic beverages
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - 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 (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.

Directions

  • do not take more than directed
  • adults and children 12 years and over:
    • take 2 caplets with water every 6 hours as needed
    • do not exceed 6 caplets in a 24 hour period or as directed by a doctor
    • children under 12 years: ask a doctor

Other Information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid excessive heat and humidity
  • tamper-evident sealed packets
  • do not use if packet opened or torn

Inactive Ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide

Questions?

1-866-651-3660 Monday-Friday
8:00am-5:00pm EST

Principal Display Panel - 2 Capsule Packet Box

This product is not manufactured or distributed by
Chattanooga Medicine Company
Owner of the registered trademark Pamprin®.

Product #1472

Cramp Tabs

Pain Reliever/Fever Reducer
Diurectic, Antihistamine

Active ingredient:

Acetaminophen
Pamabrom,
Pyrilamine maleate

  • Helps relieve minor aches, pains and water
    retention associated with the menstrual period
  • These quality comfort tablets are formulated and packaged for use in the
    workplace and meet ANSI Z308.1-2021 standards. They are sealed in
    tamper-evident packets for safety and convenience.

    80 Caplets ∙ 2 Caplets Per Packet

    Principal Display Panel (2 Capsule Packet Box)

    Principal Display Panel (2 Capsule Packet Box)

* Please review the disclaimer below.