Cramp Tabs

Cramp Tabs
SPL v1
SPL
SPL Set ID c090807d-03b7-42d4-be41-f6240a3b330f
Route
ORAL
Published
Effective Date 2024-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Bromotheophylline (25 mg) Pyrilamine (15 mg)
Inactive Ingredients
Starch, Corn Croscarmellose Sodium Crospovidone, Unspecified Fd&c Blue No. 1 Aluminum Lake Fd&c Red No. 40 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Shellac Silicon Dioxide Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;679 Shape: capsule Color: purple Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-26

Description

Drug Facts


Medication Information

Description

Drug Facts

Use

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

  • headache
  • bloating
  • cramps
  • backache
  • muscular aches
  • muscular aches
  • irritability
  • water-weight gain
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 53414-9

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

Section 55105-1
Active ingredient (In Each Caplet) Purpose
Acetaminophen 500mg pain reliever/fever reducer
Pamabrom 25mg diuretic
Pyrilamine maleate 15 mg Antihistamine
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
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
Questions?

1-866-651-3660 Monday-Friday

8:00am-5:00pm EST

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.
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
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

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.
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
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

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Structured Label Content

Use

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

  • headache
  • bloating
  • cramps
  • backache
  • muscular aches
  • muscular aches
  • irritability
  • water-weight gain
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredient (In Each Caplet) Purpose
Acetaminophen 500mg pain reliever/fever reducer
Pamabrom 25mg diuretic
Pyrilamine maleate 15 mg Antihistamine
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
Do Not Use (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
Questions?

1-866-651-3660 Monday-Friday

8:00am-5:00pm EST

Allergy Alert (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.
Liver Warning (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
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

When Using This Product (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 (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.
Ask A Doctor Before Use If You Have (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
Principal Display Panel 2 Capsule Packet Box (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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)