FDA Label for Pamprin Max Menstrual Pain Relief

Drug Facts

Active Ingredient (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

^*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Pain reliever

Diuretic

Uses

for the temporary relief of these symptoms assosciated 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. 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 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: • take a blood thinning (anticoagulant) or steroid drug • have had stomach ulcers or bleeding problems • are age 60 or older • 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.

Overdosage

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 children12 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 Ingredient

fractionated coconut oil, hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, red 27 Lake, red 40 lake, silica, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide

Questions Or Comments?

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Focus Consumer Healthcare

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Focus Consumer Healthcare, LLC

801 Broad Street

Chattanooga, TN, 37402

2017 Focus Consumer

Healthcare, LLC

0044932-02

IF PRINTED INNER SEAL ON BOTTLE IS BROKEN OR MISSING, DO NOT USE.

Easy-open bottle with child-resistant packaging. Purchase only if carton end flaps are sealed.

Package Label.Principal Display Panel

Maximum Strength

Pamprin

MAX FORMULA

for Complete Relief of

• Cramps
• Headache
• Backache
• Fatigue

Menstrual Pain Relief

Contains Acetaminophen, Aspirin (NSAID) & Caffeine

24 Caplets

label - pamprin1