Pamprin Cramp Menstrual Pain Relief

Dosage form: tablet
Ingredients: ACETAMINOPHEN 250mg, MAGNESIUM SALICYLATE 250mg, PAMABROM 25mg
Labeler: Chattem, Inc.
NDC Code: 41167-3002

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Pamprin Cramp Menstrual Pain Relief

Drug Facts

Active ingredients

(in each caplet)

Acetaminophen 250 mg

Magnesium salicylate (NSAID*) 250 mg

Purpose

Pain reliever

Active ingredients

(in each caplet)

Pamabrom 25 mg

Purpose

Diuretic

*nonsteroidal anti-inflammatory drug

Uses

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

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

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Magnesium salicylate may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

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

  • more than 8 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if
  • you have liver disease
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic

Ask a doctor or pharmacist before use

if you are taking a prescription drug for gout, diabetes or arthritis

Stop use and ask a doctor if
  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • redness or swelling is present
  • new symptoms occur
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • ringing in the ears or loss of hearing occurs

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use magnesium salicylate during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

adults and children 12 years and over:

  • take 2 caplets with water every 6 hours as needed
  • do not exceed 8 caplets in a 24 hour period or as directed by a doctor
  • do not use more than directed (see warnings)

children under 12 years: ask a doctor

Other information

• each caplet contains: magnesium 20 mg

Inactive ingredients

carnauba wax, corn starch, croscarmellose sodium, crospovidone, FD&C blue #1, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, propylene glycol, silicon dioxide, stearic acid, titanium dioxide (224-181)

PRINCIPAL DISPLAY PANEL

Maximum Strength
Pamprin®
CRAMP FORMULA

for Complete Relief of

Cramps Headache
Bloating Backache
Menstrual Pain Relief

Caffeine Free with
Pamabrom 16 Caplets
See new warnings information -

Acetaminophen & Magnesium
Salicylate (NSAID)

PAMPRIN CRAMP MENSTRUAL PAIN RELIEF 
acetaminophen and magnesium salicylate and pamabrom tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-3002
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
MAGNESIUM SALICYLATE (SALICYLIC ACID) MAGNESIUM SALICYLATE250 mg
PAMABROM (BROMOTHEOPHYLLINE) PAMABROM25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
FD&C BLUE NO. 1 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
POVIDONE 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize20mm
FlavorImprint CodePAMPRIN
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-3002-11 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
116 TABLET (16 TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/01/1983
Labeler - Chattem, Inc. (003336013)

Revised: 06/2012
 
Chattem, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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