CRAMP TABS- acetaminophen, pamabrom, and pyrilamine maleate capsule, coated

Cramp Tabs by

Drug Labeling and Warnings

Cramp Tabs by is a Otc medication manufactured, distributed, or labeled by JHK DBA American Safety & First Aid, LNK International, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (In Each Caplet)	Purpose
Acetaminophen 500mg	pain reliever/fever reducer
Pamabrom 25mg	diuretic
Pyrilamine maleate 15 mg	Antihistamine

Use

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

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

Warnings

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.

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

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

INGREDIENTS AND APPEARANCE

CRAMP TABS 
acetaminophen, pamabrom, and pyrilamine maleate capsule, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73598-1472
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6)	PAMABROM	25 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	15 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PURPLE	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	44;679
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73598-1472-1	40 in 1 BOX	06/26/2024
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M027	06/26/2024

Labeler - JHK DBA American Safety & First Aid (867236309)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, INC		832867837	MANUFACTURE(73598-1472)