Premsyn Pms Premenstrual Pain Relief Tablet
FDA Label NDC 71687-3102

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Focus Consumer Healthcare, Llc for the product Premsyn Pms Premenstrual Pain Relief (NDC 71687-3102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Purposes

→ Uses

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Overdosage

→ Directions

→ Inactive Ingredients

→ Questions Or Comments?

→ Other

→ Package Label.principal Display Panel

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