NDC | 47682-003-33, 47682-003-48, 47682-003-99 |
Set ID | 89beca67-8ae0-439b-8964-2bf194e9ca82 |
Category | HUMAN OTC DRUG LABEL |
Packager | Unifirst First Aid Corporation |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- 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.
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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 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-003-48 125 in 1 BOX 12/30/2008 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/30/2008 Labeler - Unifirst First Aid Corporation (832947092) Establishment Name Address ID/FEI Business Operations Prestige Packaging 080667761 relabel(47682-003) , repack(47682-003)