FDA Label for Green Guard Extra Strength Pain Relief
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Green Guard Extra Strength Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Unifirst First Aid Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Otc - Active Ingredient
Active ingredients (in each caplet)
Aspirin 500 mg (NSAID)*
Caffeine 32.5 mg
*nonsteroidal anti-inflammatory drug
Otc - Purpose
Purpose
Pain reliever
Pain reliever aid
Indications & Usage
Uses
for the temporary relief of
■ backache pain
■ muscle aches and pains
■ minor aches and pains of arthritis
Warnings
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert:
Aspirin may cause a severe allergic reaction which may include:
■ hives
■ shock
■ facial swelling
■ asthma (wheezing)
Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
■ take more or for a longer time than directed
■ take a blood thinning (anticoagulant) or steroid drug
■ are age 60 or older
■ have 3 or more alcohol drinks every day while using this product
■ have had stomach ulcers or bleeding problems
■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
Otc - Do Not Use
Do not use
■ if you are allergic to aspirin or any other pain reliever/fever reducer.
■ if you have ever had an allergic reaction to this product or any of its ingredients
Otc - Ask Doctor
Ask a doctor before use if
■ stomach bleeding warning applies to you
■ you have a history of stomach problems, such as heartburn
■ you have asthma
■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
■ you are taking a diuretic
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug for
■ gout
■ diabetes
■ arthritis
Otc - Stop Use
Stop use and ask a doctor if
■ an allergic reaction occurs. Seek medical help right away.
■ you experience any of the following signs of stomach bleeding: ■ vomit blood ■ have bloody or black stools ■ feel faint ■ have stomach pain that does not get better
■ ringing in the ears or a loss of hearing occurs
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present
■ new symptoms occur
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center
(1-800-222-1222) right away.
Dosage & Administration
Directions
■ drink a full glass of water with each dose
Adults and children: (12 years and over) take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours
Children under 12 years: do not use unless directed by a doctor
Other Safety Information
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
Inactive Ingredient
Inactive ingredients
corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate
Otc - Questions
Questions or comments? 1-800-869-6970
Package Label.Principal Display Panel
Extra Strength Pain Relief™
Green Guard
Alivio al dolor extra fuerte
Aspirin (NSAID) / Aspirina (AINE) 500 mg
Caffeine / Cafeina 32.5 mg
Pull tp Open
Tire Para Abrir
40 packet of 2 Caplets
80 Caplets
Order #2180
Distributed by Green Guard®
St Louis, MO 63045
* Please review the disclaimer below.