Green Guard Maximum Non-aspirin Tablet, Film Coated
FDA Label NDC 47682-009

16 label sections · Submitted to the FDA by Unifirst First Aid Corporation · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Green Guard Maximum Non-aspirin (NDC 47682-009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Active Ingredient

Active ingredient (in each tablet)

Acetaminophen 500 mg

Otc - Purpose

Purpose

Pain reliever/fever reducer

Indications & 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

Warnings

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.

Otc - 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 are allergic to acetaminophen or any of the inactive ingredients in this product

Otc - Ask Doctor

Ask a doctor before use if you have

  • liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if

  • you are taking the blood thinning drug warfarin

Otc - Stop Use

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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.

Dosage & 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

Other Safety Information

Other information

  • store at room temperature 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*, polyethylene glycol*, povidone (K-30)*, pregelatinized starch*, purified water*, sodium starch glycolate*, stearic acid*, titanium dioxide*

* m ay contain

Otc - Questions

Questions or comments? 1-800-869-6970

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

* Please review the disclaimer below.