GOODYS- acetaminophen, aspirin and caffeine powder
GlaxoSmithKline Consumer Healthcare LP
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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Drug Facts
Active ingredients (in each powder)
Acetaminophen 325 mg
Aspirin (NSAID*) 500 mg
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Uses
- •
- temporarily relieves minor aches and pains due to:
- ∘
- headache
- ∘
- menstrual cramps
- ∘
- backache
- ∘
- muscular aches
- ∘
- toothache
- ∘
- colds
- •
- 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 may cause a severe allergic reaction which may include:
- •
- hives
- •
- facial swelling
- •
- shock
- •
- 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.
Directions
- •
- 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.
Inactive ingredients
colloidal silicon dioxide, flavors, guar gum, mannitol, microcrystalline cellulose, sucralose
Questions or comments?
1-866-255-5197 (English/Spanish) weekdays
TAMPER EVIDENT FEATURE: DO NOT USE IF PACKET IS DAMAGED OR OPEN.
Distributed by:
GlaxoSmithKline
Consumer Healthcare, L.P.
Moon Township, PA 15108
©2011 GlaxoSmithKline
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.
www.goodyspowder.com
| GOODYS
acetaminophen, aspirin, and caffeine powder |
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| Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212) |