FDA Label for Acetaminophen , Caffeine And Pyrilamine Maleate

Active Ingredient (In Each Gelcap)

Acetaminophen USP 500mg
Caffeine USP 60mg
Pyrilamine maleate USP 15mg

Otc - Purpose

purpose

• Pain reliever
• Diuretic
• Antihistamine

Indications & Usage

Uses

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

• cramps

• bloating

• waterweight gain

• headache

• backache

• muscle aches

• fatigue

Warnings

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 6 gelcap in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions.
Symptoms may include: • hives • blisters • rash • skin reddening • facial swelling • asthma (wheezing) • shock
If a skin or general allergic reaction occurs, stop use and seek medical help right away.

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
• if you have ever had an allergic reaction to this product or any of its ingredients

Otc - Ask Doctor

Ask a doctor before use if you have

• liver disease

• glaucoma

• difficulty in urination due to enlargement of the prostate gland

• a breathing problem such as emphysema or chronic bronchitis

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 drinks
• excitability may occur, especially in children
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• limit the use of caffeine-containing medications, foods, or beverages beacuse too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Otc - Stop Use

Stop use and ask a doctor if
• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days

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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.
Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Dosage & Administration

Directions
• do not take more than the recommended dose
• adults and children 12 years and older: take 2 gelcap with water
• repeat every 6 hours as needed
• do not exceed 6 gelcap per day
• children under 12 years: consult a doctor

Other Safety Information

store at room temperature.

Inactive Ingredient

Inactive ingredients

croscarmellose sodium, D&C red 33 aluminum lake, edible black printing ink, ethyl cellulose, FD&C blue 1 aluminum lake, gelatin, glycerin, hydroxypropyl methylcellulose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, pregelatinized potato starch, purified water, PVPK-30, sorbitol sorbitan solution, talc, titanium dioxide, triacetin.

Package Label.Principal Display Panel

label - gelcap 1500