Label: GREEN GUARD PAIN AND ACHE RELIEF- acetaminophen, aspirin, salicylamide and caffeine tablet
- NDC Code(s): 47682-003-33, 47682-003-48, 47682-003-99
- Packager: Unifirst First Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 23, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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.
- SPL UNCLASSIFIED SECTION
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SPL UNCLASSIFIED SECTION
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
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SPL UNCLASSIFIED SECTION
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
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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.
- 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 DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
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STOP USE
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
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PREGNANCY OR BREAST FEEDING
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
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KEEP OUT OF REACH OF CHILDREN
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.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
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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
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INGREDIENTS AND APPEARANCE
GREEN GUARD PAIN AND ACHE RELIEF
acetaminophen, aspirin, salicylamide and caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 110 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 162 mg SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE 152 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.4 mg Inactive Ingredients Ingredient Name Strength 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 Color orange (orange) Score no score Shape ROUND (ROUND) Size 11mm Flavor Imprint Code FR;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-003-33 50 in 1 BOX 12/30/2008 03/01/2024 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-003-48 125 in 1 BOX 12/30/2008 03/01/2024 2 NDC:47682-003-99 2 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:47682-003-99 2 in 1 PACKET; Type 0: Not a Combination Product 12/30/2008 03/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/30/2008 03/01/2024 Labeler - Unifirst First Aid Corporation (832947092) Establishment Name Address ID/FEI Business Operations Prestige Packaging 080667761 pack(47682-003)