GREEN GUARD PAIN AND ACHE RELIEF- acetaminophen, aspirin, salicylamide and caffeine tablet 
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.

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Green Guard Pain & Ache Relief

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 110 mg

Aspirin (NSAID)* 162 mg

Caffeine 32.4 mg

Salicylamide (NSAID)* 152 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Pain reliever/Fever reducer

Adjuvant

Pain reliever aid

Uses

temporarily relieves minor aches and pains associated with

  • headache
  • muscular aches
  • minor arthritis pain
  • back pain
  • colds
  • toothache
  • menstrual cramps

Temporarily reduces fever.

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 (NSAIDs) may cause a severe allergic reaction which may include:

■ hives ■ facial swelling ■ asthma (wheezing) ■ shock

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening ■ blisters ■ rash

If a skin or allergic reaction occurs, stop use and seek medical help right away.

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning: This product contains nonsteriodal anti-inflammatory drugs (NSAIDs), which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine- containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat

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 pain for more than 10 days unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • with any other pain reliever/fever reducer

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems (such as heartburn, upset stomach or stomach pain)
  • you have heart disease, liver cirrhosis, or kidney disease
  • you have asthma or high blood pressure
  • you are taking a diuretic

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

■ anticoagulation

■ diabetes

■ gout

■ arthritis

Ask a doctor or pharmacist before use if you have

■ liver disease

When using this product do not exceed recommended dose

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better
  • symptoms do not improve
  • pain or fever gets worse
  • ringing in the ears or loss of hearing occurs
  • new symptoms occur

If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use aspirin and salicylamide during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery

Keep out of reach of children.

Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage.

In case of 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 hours as needed with a full glass of water. Do not exceed 8 tablets in 24 hours or as directed by a doctor.

Children under 12 years of age: ask a doctor

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • avoid excessive heat and humidity
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

FD&C yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch, stearic acid.

Questions or Comments? 1-800-869-6970

Green Guard Pain & Ache Relief

Pain & Ache Relief™

Tabletas para aliviar el doior

Green Guard®

Pull Out

Tire Para Abrir

Acetaminophen/Acetaminofeno 110 mg

Aspirin (NSAID)/Aspirina (AINE) 162 mg

Salicylamide (NSAID)/ Salicilamida (AINE)152 mg

Caffeine/Cafeina 32.4 mg

Pain Reliever & Fever Reducer/ Alivia el dolor y reduce la fiebre

125 packets of 2 tablets

250 Tablets Order #2210

Distributed by Green Guard®, St Louis, MO 63045

811R GG PA

GREEN GUARD PAIN AND ACHE RELIEF 
acetaminophen, aspirin, salicylamide and caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN110 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN162 mg
SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE152 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.4 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colororange (orange) Scoreno score
ShapeROUND (ROUND) Size11mm
FlavorImprint Code FR;2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47682-003-3350 in 1 BOX12/30/200803/01/2024
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:47682-003-48125 in 1 BOX12/30/200803/01/2024
2NDC:47682-003-992 in 1 PACKET; Type 0: Not a Combination Product
3NDC:47682-003-992 in 1 PACKET; Type 0: Not a Combination Product12/30/200803/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/30/200803/01/2024
Labeler - Unifirst First Aid Corporation (832947092)
Establishment
NameAddressID/FEIBusiness Operations
Prestige Packaging080667761pack(47682-003)

Revised: 2/2023
 
Unifirst First Aid Corporation