Green Guard Cramp Relief

Green Guard Cramp Relief
SPL v6
SPL
SPL Set ID e6edff0f-94e4-7eba-e053-2a95a90a1d57
Route
ORAL
Published
Effective Date 2022-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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

Warnigs

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

Menstrual Cramp Relief™

Pull to Open

Tire Para Abrir

Acetaminophen 500 mg / Acetaminofeno 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg / Maleato de pirilamina 15 mg

Green Guard®

Relief of menstrual pain, water retention and bloating

Para el alivio de dolores menstruales,

retencion de liquidos e hinchazon

40 Packets of 2 Caplets

80 Caplets

Order #2380

Distributed by Green Guard®

St Louis, MO 63045

Section 53413-1

Questions or comments? 1-800-869-6970

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

■ 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)

Warnigs

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)

Menstrual Cramp Relief™

Pull to Open

Tire Para Abrir

Acetaminophen 500 mg / Acetaminofeno 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg / Maleato de pirilamina 15 mg

Green Guard®

Relief of menstrual pain, water retention and bloating

Para el alivio de dolores menstruales,

retencion de liquidos e hinchazon

40 Packets of 2 Caplets

80 Caplets

Order #2380

Distributed by Green Guard®

St Louis, MO 63045

Section 53413-1 (53413-1)

Questions or comments? 1-800-869-6970

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

■ tamper evident sealed packets

■ do not use any opened or torn packets


Advanced Ingredient Data


Raw Label Data

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