GREEN GUARD CRAMP RELIEF- acetaminophen, pamabrom, pyrilamine maleate tablet, film coated

Green Guard Cramp Relief by

Drug Labeling and Warnings

Green Guard Cramp Relief by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg

PURPOSE

Purpose

Pain reliever

Diuretic

Antihistamine

INDICATIONS & USAGE

Uses

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

■ headache

■ bloating

■ cramps

■ backache

■ muscular aches

■ irritability

■ water-weight gain

WARNINGS

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.

DO NOT USE

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

ASK DOCTOR

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

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

■ taking sedatives or tranquilizers

■ taking the blood thinning drug warfarin

WHEN USING

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

STOP USE

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & 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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

QUESTIONS

Questions or comments? 1-800-869-6970

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

GREEN GUARD CRAMP RELIEF 
acetaminophen, pamabrom, pyrilamine maleate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-049
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	15 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6)	PAMABROM	25 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SHELLAC (UNII: 46N107B71O)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	purple	Score	no score
Shape	CAPSULE (Caplet)	Size	17mm
Flavor		Imprint Code	44;679
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-049-80	40 in 1 BOX	09/26/2022
1	NDC: 47682-049-99	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-049-47	100 in 1 BOX	09/26/2022
2	NDC: 47682-049-99	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M027	09/26/2022

Labeler - Unifirst First Aid Corporation (832947092)