Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg Softgelatin Capsules

Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg Softgelatin Capsules
SPL v1
SPL
SPL Set ID 45478958-ad86-4d87-e063-6394a90a3c45
Route
ORAL
Published
Effective Date 2025-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (60 mg) Pyrilamine (15 mg) Acetaminophen (500 mg)
Inactive Ingredients
Croscarmellose Sodium Water Isopropyl Alcohol Microcrystalline Cellulose D&c Red No. 33 Aluminum Lake Starch, Potato Gelatin, Unspecified Glycerin Ethylcellulose, Unspecified Hypromellose, Unspecified Titanium Dioxide Sorbitol Sorbitan Talc Triacetin Magnesium Stearate Povidone K30 Fd&c Blue No. 1 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: blue Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-12

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

All Sections (JSON)