FDA Label for Cramp Tabs

View Indications, Usage & Precautions

Cramp Tabs Product Label

The following document was submitted to the FDA by the labeler of this product Jhk Dba American Safety & First Aid. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.