Unishield Pms Relief

Unishield Pms Relief
SPL v2
SPL
SPL Set ID e7116d33-86be-35a7-e053-2a95a90a8532
Route
ORAL
Published
Effective Date 2022-08-31
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
Starch, Corn Croscarmellose Sodium Crospovidone Fd&c Blue No. 2--aluminum Lake Fd&c Red No. 40 Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Shellac Silicon Dioxide Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;679 Shape: capsule Color: purple Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-26

Description

Drug Facts


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

If a skin reaction occurs, stop use and seek medical help right away.

Indications and Usage

Uses

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

■ headache

■ bloating

■ cramps

■ backache

■ muscular aches

■ irritability

■ water-weight gain

Dosage and Administration

Directions

do not take more than directed

Adults and children: (12 years and over)

■ take 2 caplets with water every 6 hours as needed

■ do not exceed 6 caplets in a 24 hour period or as directed by a doctor

Children under 12 years: ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 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

■ excitability may occur, especially in children

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ use caution when driving a motor vehicle or operating machinery

Section 50568-5

Ask a doctor or pharmacist before use if you are

■ taking sedatives or tranquilizers

■ taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if you have

■ difficulty in urination due to enlargement of the prostate gland

■ a breathing problem such as emphysema or chronic bronchitis

■ liver disease

■ glaucoma

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

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

Unishield

PMS Relief

Menstrual Relief

80 caplets / 2 Caplets Per Packet

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine Maleate 15 mg

Pain Reliever, Diuretic, Antihistamine

Pull To Open

This Package is for Households Without Young Children.

• Reduces water-weight gain

• Relieves headaches, backaches and muscular aches and pains

Relieves Cramps and Bloating

Tamper Evident Unit Dose Packets

Section 53413-1

Questions or comments? 800-480-5855

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever

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

■ store at 77°F (25°C); excursions permitted between 59°-86°F (15°-30°C)

■ tamper-evident sealed packets

■ do not use any opened or torn packets


Structured Label Content

Indications and Usage (34067-9)

Uses

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

■ headache

■ bloating

■ cramps

■ backache

■ muscular aches

■ irritability

■ water-weight gain

Dosage and Administration (34068-7)

Directions

do not take more than directed

Adults and children: (12 years and over)

■ take 2 caplets with water every 6 hours as needed

■ do not exceed 6 caplets in a 24 hour period or as 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

If a skin reaction occurs, stop use and seek medical help right away.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 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

■ excitability may occur, especially in children

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ use caution when driving a motor vehicle or operating machinery

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

■ taking sedatives or tranquilizers

■ taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ difficulty in urination due to enlargement of the prostate gland

■ a breathing problem such as emphysema or chronic bronchitis

■ liver disease

■ glaucoma

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

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)

Unishield

PMS Relief

Menstrual Relief

80 caplets / 2 Caplets Per Packet

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine Maleate 15 mg

Pain Reliever, Diuretic, Antihistamine

Pull To Open

This Package is for Households Without Young Children.

• Reduces water-weight gain

• Relieves headaches, backaches and muscular aches and pains

Relieves Cramps and Bloating

Tamper Evident Unit Dose Packets

Section 53413-1 (53413-1)

Questions or comments? 800-480-5855

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 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

■ store at 77°F (25°C); excursions permitted between 59°-86°F (15°-30°C)

■ tamper-evident sealed packets

■ do not use any opened or torn packets


Advanced Ingredient Data


Raw Label Data

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