Pamprin Multi-symptom Tablet
FDA Label NDC 71687-3003

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 Pamprin Multi-symptom (NDC 71687-3003). 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, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Do Not Use

→ Otc - Ask Doctor

→ Otc - Ask Doctor/pharmacist

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Overdosage

→ Directions

→ Inactive Ingredient

→ 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

Otc - Purpose

Purposes

Pain reliever
Diuretic
Antihistamine

Indications & Usage

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

Otc - Do Not Use

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.

Otc - Ask Doctor

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers

Otc - When Using

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

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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 Ingredient

blue 2, candelilla wax, corn starch, ethylparaben, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylparaben, red 40, sodium starch glycolate, stearic acid, talc, titanium dioxide