Label: GOODYS- acetaminophen, aspirin and caffeine powder
- NDC Code(s): 0135-0462-01, 0135-0462-02, 0135-0462-03, 0135-0462-05
- Packager: GlaxoSmithKline Consumer Healthcare LP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredients (in each powder)
Acetaminophen 325 mg
Aspirin (NSAID*) 500 mg
Caffeine 65 mg
*nonsteroidal anti-inflammatory drugClose
Pain reliever/fever reducer
Pain reliever/fever reducer
Pain reliever aidClose
temporarily relieves minor aches and pains due to:
- menstrual cramps
- muscular aches
- temporarily reduces fever
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 may cause a severe allergic reaction which may include:
- facial swelling
- asthma (wheezing)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 powders 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
Stomach bleeding warning: This product contains an NSAID, 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 longer time than directed
Do not use
- if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
- 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
- you have liver disease
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
Ask a doctor or pharmacist before use if you are
taking a prescription drug for diabetes, gout, or arthritis
When using this product
limit the use of caffeine-containing drugs, foods, or drinks because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away
you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- have stomach pain that does not get better
- vomit blood
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms appear
- ringing in the ears or a loss of hearing occurs
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use aspirin 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.
Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not take more than directed (see overdose warning)
- adults and children 12 years of age and over: place 1 powder on tongue every 6 hours, while symptoms persist. Drink a full glass of water with each dose, or may stir powder into a glass of water or other liquid.
- do not take more than 4 powders in 24 hours unless directed by a doctor.
- children under 12 years of age: ask a doctor.
- Other information
- store below 25°C (77°F)
- Inactive ingredients
colloidal silicon dioxide, flavors, guar gum, mannitol, microcrystalline cellulose, sucraloseClose
- Questions or comments?
1-866-255-5197 (English/Spanish) weekdays
TAMPER EVIDENT FEATURE: DO NOT USE IF PACKET IS DAMAGED OR OPEN.
Consumer Healthcare, L.P.
Moon Township, PA 15108
GOODY'S is a registered trademark of the GlaxoSmithKline group of companies.
TO OPEN CHILD-RESISTANT PACKAGE
1.Shake pack so powder settles on bottom.
2. Pinch and tear at either arrow or use scissors.
3. Tilt head back and pour powder onto tongue.
- Principal Display Panel
COOL ORANGE EXTRA STRENGTH
PAIN RELIEVER•FEVER REDUCER/ PAIN RELIEVER AID
FAST PAIN RELIEF
24 SEALED POWDER PACKS
- INGREDIENTS AND APPEARANCE
acetaminophen, aspirin, and caffeine powder
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0135-0462 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg ASPIRIN (ASPIRIN) ASPIRIN 500 mg CAFFEINE (CAFFEINE) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE GUAR GUM MANNITOL CELLULOSE, MICROCRYSTALLINE SUCRALOSE Product Characteristics Color WHITE Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0462-01 4 in 1 CARTON 2 NDC:0135-0462-02 24 in 1 CARTON 3 NDC:0135-0462-03 1 in 1 PACKAGE 4 NDC:0135-0462-05 36 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/23/2011 12/31/2014 Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)