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PAMPRIN MAX MENSTRUAL PAIN RELIEF (acetaminophen and aspirin and caffeine) tablet
[Chattem, Inc.]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

Drug Facts

Active ingredients

(in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Purpose

Pain reliever

Active ingredients

(in each caplet)

Caffeine 65 mg

Purpose

Diuretic

*nonsteroidal anti-inflammatory drug

Uses

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

  • cramps
  • headache
  • backache
  • fatigue
  • bloating

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: Aspirin 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

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Do not use

• if you are allergic to aspirin or 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 aspirin 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

Inactive ingredients

D&C Red No. 27 Lake, FD&C Red No. 40 Lake, fractionated coconut oil, hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide (245-171)

PRINCIPAL DISPLAY PANEL

Maximum Strength
Pamprin®
MAX FORMULA

for Complete Relief of

 Cramps  Headache
 Backache  Fatigue
Menstrual Pain Relief

with Caffeine 24 caplets

See new warnings information -

Acetaminophen & Aspirin (NSAID)

PRINCIPAL DISPLAY PANEL
Maximum Strength Pamprin Max Formula with Caffeine

INGREDIENTS & APPEARANCE

PAMPRIN MAX MENSTRUAL PAIN RELIEF 
acetaminophen and aspirin and caffeine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41167-3006
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
ASPIRIN (ASPIRIN) ASPIRIN250 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 
FD&C RED NO. 40 
MEDIUM-CHAIN TRIGLYCERIDES 
HYPROMELLOSES 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
STARCH, CORN 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize18mm
FlavorImprint Code MAX
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-3006-51 in 1 CARTON
124 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/01/2006
Labeler - Chattem, Inc. (003336013)

Revised: 6/2012
 
Chattem, Inc.