GREEN GUARD MAXIMUM NON-ASPIRIN- acetaminophen tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
Unifirst First Aid Corporation
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer For the temporary relief of minor aches and pains associated with - headache - toothache - minor arthritis pain - muscular aches - common cold - menstrual cramps For the reduction of fever.
Authorization status:
OTC monograph not final
Authorization number:
47682-010-33, 47682-010-48, 47682-010-99

GREEN GUARD MAXIMUM NON-ASPIRIN- acetaminophen tablet, film coated

Unifirst First Aid Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Green Guard® Maximum Strength Non-Aspirin 2

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

For the temporary relief of minor aches and pains associated with

headache

toothache

minor arthritis pain

muscular aches

common cold

menstrual cramps

For the reduction of fever.

Warnings

Liver warning:

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

more than 8 tablets 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.

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

pain or fever persists or gets worse

new symptoms occur

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 this adult strength product to children under 12 years of age;

this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

store at room temperature 59º-86ºF (15º-30ºC)

tamper-evident sealed packets

do not use any opened or torn packets

Inactive ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*,

pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

* m ay contain

Questions or comments? 1-800-869-6970

Green Guard Max Non-Aspirin 500 mg Label

Maximum Strength

Non-Aspirin

relief

Compare Active Ingredient To Extra Strength Tylenol®

Green Guard®

Pull Out

Tire Para Abrir

Acetaminophen 500 mg/Acetaminofeno 500 mg

Pain Reliever/Fever Reducer

Alivia el Dolor/Reduce la Fiebre

Tylenol® is a Registered Trademark of McNeil Consumer Products

125 Packets of 2 Tablets

250 Tablets

Order #2222

Distributed by Green Guard® St Louis. MO 63045

An FDA Regulated Facility

GREEN GUARD MAXIMUM NON-ASPIRIN

acetaminophen tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:476 8 2-0 10

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

50 0 mg

Inactive Ingredients

Unifirst First Aid Corporation

Ingredient Name

Stre ng th

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

white (white)

S core

no sco re

S hap e

ROUND (ROUND)

S iz e

12mm

Flavor

Imprint Code

FR;33

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:476 8 2-0 10 -33

50 in 1 BOX

12/30 /20 0 8

1

NDC:476 8 2-0 10 -9 9

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:476 8 2-0 10 -48

125 in 1 BOX

12/30 /20 0 8

2

NDC:476 8 2-0 10 -9 9

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

12/30 /20 0 8

Labeler -

Unifirst First Aid Corporation (832947092)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Prestige Packaging

170 8 379 6 2

relabel(476 8 2-0 10 ) , repack(476 8 2-0 10 )

Revised: 6/2020

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