GREEN GUARD PMS RELIEF- acetaminophen, pamabrom tablet, film coated

Green Guard PMS Relief by

Drug Labeling and Warnings

Green Guard PMS 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 ingredients (in each tablet)

Acetaminophen 325 mg

Pamabrom 25 mg

Purpose

Pain reliever/fever reducer

Diuretic

Uses

For the temporary relief of minor aches and pains associated with

• headache
• backaches
• menstrual cramps

Temporarily relieves water-weight gain, bloating, swelling and full feeling associated with the premenstrual and menstrual periods.

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.

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.
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have

• liver disease

Ask a doctor or pharmacist before use if

• you are taking the blood thinning drug warfarin

Stop using and ask a doctor if

• symptoms do not improve
• new symptoms occur
• pain or fever persists or gets worse
• redness or swelling is present

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not use more than directed

Adults and children: (12 years and older)

Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

• read all product information before using
• store at room temperature 59º-86ºF (15º-30ºC)
• avoid excessive heat and humidity
• tamper-evident sealed packets
• do not use any opened or torn packets

Inactive ingredients

corn starch, D&C yellow #10, FD&C blue #1, FD&C red #40, microcrystalline cellulose, povidone, stearic acid, sucrose

Questions or comments?

1-800-869-6970

Green Guard PMS Label

PMS relief™

GREEN GUARD®

Pull to Open

Tire Para Abrir

Acetaminophen 325mg/Acetaminofeno 325mg

Pamabrom 25mg

Tabletas para el alivio

del syndrome premenstrual

50 Packets of 2 Tablets

100 Tablets

Order #2270

Distributed by Green Guard®, St Louis, MO 63045

An FDA Regulated Facility

INGREDIENTS AND APPEARANCE

GREEN GUARD PMS RELIEF 
acetaminophen, pamabrom tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-016
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6)	PAMABROM	25 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	11mm
Flavor		Imprint Code	FR;7
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-016-33	50 in 1 BOX	12/30/2008
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-016-48	125 in 1 BOX	12/30/2008
2	NDC: 47682-016-99	2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-016-99	2 in 1 PACKET; Type 0: Not a Combination Product	12/30/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	12/30/2008

Labeler - Unifirst First Aid Corporation (832947092)