FDA Label for Premsyn Pms Premenstrual Pain Relief

Drug Facts

Active Ingredients (in each caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg

Purposes

Pain reliever

Antihistamine

Diuretic

Uses

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

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

Warnings

Allergy Warning: 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

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.

Ask A Doctor Before Use If You Have

• liver disease
  
• glaucoma
  
• a breathing problem such as emphysema or chronic bronchitis
  
• difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use

if you are

• taking the blood thinning drug warfarin 
  
• taking sedatives or tranquilizers

When Using This Product

• you may get drowsy, avoid alcoholic beverages
  
• alcohol, sedatives and tranquilizers may increase drowsiness
  
• use caution when driving or operating machinery
  
• excitability may occur, especially in children

Stop Use And Ask A Doctor If

• pain gets worse or lasts for more than 10 days
  
• fever gets worse or lasts for more than 3 days
  
• new symptoms occur
  
• redness or swelling is present

If Pregnant Or Breast-Feeding,

ask a health professional before use.

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.

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 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

Blue 2, Candelilla wax, corn starch, ethylparaben, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregalatinized starch, propylaparaben, red 40, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments?

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©2017 Focus Consumer Healthcare, LLC

www.pamprin.com

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 Premsyn pms ®

Prementrual Syndrome Relief of • Tension • Irritability • Bloating

Aspirin free and Caffeine free with Acetaminophen, Pamabrom and Pyrilamine Maleate

New Coated Caplet Same Relief

40 Caplets