Label: GOOD SENSE HEADACHE RELIEF- acetaminophen, aspirin, caffeine tablet, film coated
- NDC Code(s): 0113-1855-27
- Packager: L. Perrigo Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 5, 2024
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- Official Label (Printer Friendly)
- Active ingredients (in each geltab)
- Purposes
- Uses
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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: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
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- have 3 or more alcoholic drinks every day while using this product
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- 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
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- if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if
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- you have liver disease
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- stomach bleeding warning applies to you
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- you have a history of stomach problems, such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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- you are taking a diuretic
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- you have asthma
Ask a doctor or pharmacist before use if you are
taking
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- a prescription drug for diabetes, gout, or arthritis
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- any other drug, or are under a doctor’s care for any serious condition
Stop use and ask a doctor if
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- an allergic reaction occurs. Seek medical help right away.
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- ringing in the ears or loss of hearing occurs
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- painful area is red or swollen
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- pain gets worse or lasts for more than 10 days
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- fever gets worse or lasts for more than 3 days
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- any new symptoms occur
These could be signs of a serious condition
- Directions
- Other information
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Inactive ingredients
black iron oxide, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltitol solution, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polyvinyl acetate phthalate, povidone, pregelatinized starch, propylene glycol, stearic acid, titanium dioxide
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- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
GOOD SENSE HEADACHE RELIEF
acetaminophen, aspirin, caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-1855 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE (UNII: XM0M87F357) CARNAUBA WAX (UNII: R12CBM0EIZ) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MALTITOL (UNII: D65DG142WK) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN, WHITE Score no score Shape ROUND Size 13mm Flavor Imprint Code M Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0113-1855-27 1 in 1 CARTON 02/18/2022 1 80 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 02/18/2022 Labeler - L. Perrigo Company (006013346)
