Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg Softgelatin Capsules
45478958-ad86-4d87-e063-6394a90a3c45
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg
Medication Information
Warnings and Precautions
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 6 softgel 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.
Indications and Usage
Uses
for the temporary relief of these symptoms associated with menstural periods:
• cramps
• bloating
• waterweight gain
• headache
• backache
• muscle aches
• fatigue
Dosage and Administration
Directions
• do not take more than the recommended dose
• adults and children 12 years and older: take 2 softgel with water
• repeat every 6 hours as needed
• do not exceed 6 softgel per day
• children under 12 years: consult a doctor
Description
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg
Section 50565-1
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.
Section 50566-9
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
Section 50567-7
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.
Section 50568-5
Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers
Section 50569-3
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
Section 50570-1
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
Section 51727-6
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.
Section 51945-4
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use
Section 55105-1
purpose
- Pain reliever
- Diuretic
- Antihistamine
Section 60561-8
store at room temperature.
Active Ingredient (in Each Softgelatin Capsule)
Acetaminophen 500mg
Caffeine 60mg
Pyrilamine maleate 15mg
Structured Label Content
Indications and Usage (34067-9)
Uses
for the temporary relief of these symptoms associated with menstural periods:
• cramps
• bloating
• waterweight gain
• headache
• backache
• muscle aches
• fatigue
Dosage and Administration (34068-7)
Directions
• do not take more than the recommended dose
• adults and children 12 years and older: take 2 softgel with water
• repeat every 6 hours as needed
• do not exceed 6 softgel per day
• children under 12 years: consult a doctor
Warnings and Precautions (34071-1)
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 6 softgel 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.
Section 50565-1 (50565-1)
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.
Section 50566-9 (50566-9)
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
Section 50567-7 (50567-7)
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.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers
Section 50569-3 (50569-3)
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
Section 50570-1 (50570-1)
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
Section 51727-6 (51727-6)
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.
Section 51945-4 (51945-4)
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use
Section 55105-1 (55105-1)
purpose
- Pain reliever
- Diuretic
- Antihistamine
Section 60561-8 (60561-8)
store at room temperature.
Active Ingredient (in Each Softgelatin Capsule) (Active ingredient (in each softgelatin capsule))
Acetaminophen 500mg
Caffeine 60mg
Pyrilamine maleate 15mg
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:36.772460 · Updated: 2026-03-14T23:11:14.961491