green guard® maximum strength non-aspirin

green guard® maximum strength non-aspirin
SPL v14
SPL
SPL Set ID 30f77d4d-839e-4d96-9f24-0254e6a47b81
Route
oral
Published
Effective Date 2023-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
hypromelloses polyethylene glycol, unspecified povidone sodium starch glycolate type a potato starch, corn stearic acid titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AZ;235 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
otc monograph drug active Since 2008-12-30

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

■ more than 4,000 mg in 24 hours, which is the maximum daily amount

■ 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.

Active Ingredient

Active ingredient (in each tablet)

Acetaminophen 500 mg

Indications and Usage

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • minor pain of arthritis
  • backache
  • the common cold
  • toothache
  • premenstrual and menstrual cramps

temporarily reduces fever

Dosage and Administration

Directions

  • do not use more than directed (see overdose warning)

Adults and children: (12 years and over) ■ take 2 tablets every 6 hours while symptoms last.

■ do not take more than 6 tablets in 24 hours, unless directed by a doctor

■ do not use for more than 10 days unless 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.I

Overdose Warning:

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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 for 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 50568-5

Ask a doctor or pharmacist before use if

  • you are taking the blood thinning drug warfarin
Section 50569-3

Ask a doctor before use if you have

  • liver disease
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 are allergic to acetaminophen or any of the inactive ingredients in this product
Section 51727-6

Inactive ingredients

corn starch*, hypromellose*, polyethylene glycol*, povidone (K-30)*, pregelatinized starch*, purified water*, sodium starch glycolate*, stearic acid*, titanium dioxide*

* m ay contain

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/fever reducer

Section 60561-8

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Green Guard Max Non Aspirin Label

Maximum Strength Non-Aspirin relief™

Acetaminophen 500 mg/Acetaminofeno 500 mg

Pain Reliever/Fever Reducer

Alivia el Dolor/Reduce la Fiebre

Compare Active Ingredient To Extra Strength Tylenol®

Green Guard®

Pull Out

Tire Para Abrir

Tylenol® is a Registered Trademark of McNeil Consumer Products

50 Packets of 2 Tablets

100 Tablets

Order #2224

Distributed by Green Guard® St Louis. MO 63045


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

■ more than 4,000 mg in 24 hours, which is the maximum daily amount

■ 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.

Active Ingredient (55106-9)

Active ingredient (in each tablet)

Acetaminophen 500 mg

Indications and Usage (34067-9)

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • minor pain of arthritis
  • backache
  • the common cold
  • toothache
  • premenstrual and menstrual cramps

temporarily reduces fever

Dosage and Administration (34068-7)

Directions

  • do not use more than directed (see overdose warning)

Adults and children: (12 years and over) ■ take 2 tablets every 6 hours while symptoms last.

■ do not take more than 6 tablets in 24 hours, unless directed by a doctor

■ do not use for more than 10 days unless directed by a doctor

Children under 12 years: Ask a doctor

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.I

Overdose Warning:

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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 for 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 50568-5 (50568-5)

Ask a doctor or pharmacist before use if

  • you are taking the blood thinning drug warfarin
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
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 are allergic to acetaminophen or any of the inactive ingredients in this product
Section 51727-6 (51727-6)

Inactive ingredients

corn starch*, hypromellose*, polyethylene glycol*, povidone (K-30)*, pregelatinized starch*, purified water*, sodium starch glycolate*, stearic acid*, titanium dioxide*

* m ay contain

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/fever reducer

Section 60561-8 (60561-8)

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Green Guard Max Non Aspirin Label (Green Guard Max Non-Aspirin Label)

Maximum Strength Non-Aspirin relief™

Acetaminophen 500 mg/Acetaminofeno 500 mg

Pain Reliever/Fever Reducer

Alivia el Dolor/Reduce la Fiebre

Compare Active Ingredient To Extra Strength Tylenol®

Green Guard®

Pull Out

Tire Para Abrir

Tylenol® is a Registered Trademark of McNeil Consumer Products

50 Packets of 2 Tablets

100 Tablets

Order #2224

Distributed by Green Guard® St Louis. MO 63045


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