Green Guard Pain Relief

Green Guard Pain Relief
SPL v6
SPL
SPL Set ID e729319a-6a2c-bfe6-e053-2a95a90a4620
Route
ORAL
Published
Effective Date 2022-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (500 mg) Caffeine (32.5 mg)
Inactive Ingredients
Microcrystalline Cellulose Starch, Corn Hypromellose, Unspecified Maltodextrin Polyethylene Glycol, Unspecified Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Imprint: 44;413 Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-26

Description

Drug Facts


Medication Information

Warnings and Precautions

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)

Indications and Usage

Uses

for the temporary relief of

■ backache pain

■ muscle aches and pains

■ minor aches and pains of arthritis

Dosage and 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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

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.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug for

■ gout

■ diabetes

■ arthritis

Section 50569-3

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

Section 50570-1

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

Section 51727-6

Inactive ingredients

corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

Section 51945-4

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

Section 53413-1

Questions or comments? 1-800-869-6970

Section 53414-9

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.

Section 55105-1

Purpose

Pain reliever

Pain reliever aid

Section 55106-9

Active ingredients (in each caplet)

Aspirin 500 mg (NSAID)*

Caffeine 32.5 mg

*nonsteroidal anti-inflammatory drug

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

■ backache pain

■ muscle aches and pains

■ minor aches and pains of arthritis

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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)

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug for

■ gout

■ diabetes

■ arthritis

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

Section 51945-4 (51945-4)

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

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. 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.

Section 55105-1 (55105-1)

Purpose

Pain reliever

Pain reliever aid

Section 55106-9 (55106-9)

Active ingredients (in each caplet)

Aspirin 500 mg (NSAID)*

Caffeine 32.5 mg

*nonsteroidal anti-inflammatory drug

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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