Fem-prin

Fem-prin
SPL v2
SPL
SPL Set ID d8516e5b-3087-4c29-9290-989cf800d34c
Route
ORAL
Published
Effective Date 2024-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bromotheophylline (25 mg) Pyrilamine (15 mg) Acetaminophen (500 mg)
Inactive Ingredients
Povidone, Unspecified Silicon Dioxide Croscarmellose Sodium Fd&c Blue No. 2--aluminum Lake Polyvinyl Alcohol, Unspecified Titanium Dioxide Magnesium Stearate Talc Crospovidone Stearic Acid Shellac Starch, Corn Fd&c Red No. 40 Microcrystalline Cellulose Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: 44;679 Shape: capsule Color: purple Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-09

Description

Active ingredient (in each caplet) Acetaminophen 500 mg Pamabrom 25 mg Pyrilamine maleate 15 mg


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

■ more than 4,000 mg of acetaminophen in 24 hours

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening

■ blisters

■ rash

Indications and Usage

Uses

for the temporary relief of minor aches, pain, and water weight gain due to mentrual cycle

Dosage and Administration

Directions

Do not take more than directed

Adults and children 12 years of age and over

■ take 2 caplets every 6 hours while symptoms persist

■ do not take more than 6 caplets in 24 hours unless directed by a doctor

Children under 12 years: ask a doctor

Description

Active ingredient (in each caplet) Acetaminophen 500 mg Pamabrom 25 mg Pyrilamine maleate 15 mg

Section 50565-1

Keep out of reach of children. 

Section 50566-9

Stop use and ask a doctor if

■ an allergic reaction occurs, seek medical help right away

■ fever worsens or lasts more than 3 days

■ pain worsens or lasts more than 10 days

■ new symptoms occur

■ redness or swelling is present

These could be signs of a serious condition.

Section 50567-7

When using this product

■ drowsiness may occur

■ avoid alcoholic beverages

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ use caution when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

Section 50568-5

Ask a doctor or pharmacist before use if 

■ you do not know if other drugs you are taking contain acetaminophen

■ you are taking sedatives or tranquilizers

■ you are taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if you have

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland

■ liver disease

■ glaucoma

Section 50570-1

Do not use

■ with any other drug containing acetaminophen (prescription or nonprescription).

Section 51727-6

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide

Section 51945-4

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Diuretic

Antihistamine

Section 55106-9

Active ingredient (in each caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg

Section 60561-8

Other information:

■ caplets enclosed in a sealed packet

■ do not use if packet is torn, cut or open

■ store at 59° to 86°F (15°-30°C)

■ avoid excessive heat and humidity

Overdose Warning:


Structured Label Content

Indications and Usage (34067-9)

Uses

for the temporary relief of minor aches, pain, and water weight gain due to mentrual cycle

Dosage and Administration (34068-7)

Directions

Do not take more than directed

Adults and children 12 years of age and over

■ take 2 caplets every 6 hours while symptoms persist

■ do not take more than 6 caplets in 24 hours unless directed by a doctor

Children under 12 years: ask a doctor

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

■ more than 4,000 mg of acetaminophen in 24 hours

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening

■ blisters

■ rash

Section 50565-1 (50565-1)

Keep out of reach of children. 

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■ an allergic reaction occurs, seek medical help right away

■ fever worsens or lasts more than 3 days

■ pain worsens or lasts more than 10 days

■ new symptoms occur

■ redness or swelling is present

These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product

■ drowsiness may occur

■ avoid alcoholic beverages

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ use caution when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if 

■ you do not know if other drugs you are taking contain acetaminophen

■ you are taking sedatives or tranquilizers

■ you are taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland

■ liver disease

■ glaucoma

Section 50570-1 (50570-1)

Do not use

■ with any other drug containing acetaminophen (prescription or nonprescription).

Section 51727-6 (51727-6)

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide

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/fever reducer

Diuretic

Antihistamine

Section 55106-9 (55106-9)

Active ingredient (in each caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg

Section 60561-8 (60561-8)

Other information:

■ caplets enclosed in a sealed packet

■ do not use if packet is torn, cut or open

■ store at 59° to 86°F (15°-30°C)

■ avoid excessive heat and humidity

Overdose Warning: (Overdose warning:)


Advanced Ingredient Data


Raw Label Data

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