ACETAMINOPHEN- acetaminophen tablet
Cardinal Health
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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Active ingredient
Acetaminophen, 325 mg
Purpose
Pain reliever/fever reducer
Uses
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- temporarily relives minor aches and pains due to:
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- headache
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- backache
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- toothache
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- premenstrual and menstrual cramps
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- the common cold
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- minor pain of arthritis
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- muscular aches
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- temporarily reduces fever
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if:
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- adult takes more than 4,000 mg of acetaminophen in 24 hours
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- child takes more than 5 doses in 24 hours
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- taken with other drugs containing acetaminophen
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- adult has 3 or more alcoholic drinks every day while using this product
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.
Do not use
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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.
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- if you are allergic to acetaminophen or any of the inactive ingredients in this product.
Ask a doctor before use if you have liver disease.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Stop use and ask a doctor if
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- pain gets worse or lasts more than 10 days (for adults) or 5 days (for children under 12 years)
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- fever gets worse or lasts more than 3 days
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- new symptoms occur
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- redness or swelling is present
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
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 (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
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do not take more than directed (see overdose warning)
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- adults and children 12 years and over
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- take 2 tablets every 4 to 6 hours while symptoms last
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- do not take more than 10 tablets in 24 hours
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- do not use for more than 10 days unless directed by a doctor
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- children 6-11 years
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- take 1 tablet every 4 to 6 hours while symptoms last
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- do not take more than 5 tablets in 24 hours
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- do not use for more than 5 days unless directed by a doctor
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- children under 6 years: ask a doctor
Other information
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- store at 20°-25°C (68°-77°F)
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- save carton for full directions and warnings
Inactive ingredients
corn starch, crospovidone, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid
Questions or comments?
1-888-341-9214
Package/Label Principal Display Panel
NDC 70000-0104-2
Pain Reliever
Acetaminophen, 325 mg
Pain Reliever/Fever Reducer
Regular Strength, Contains No Aspirin
See New Warnings
50 Tablets
Package/Label Principal Display Panel
NDC 70000-0104-2
Pain Reliever
Acetaminophen, 325 mg
Pain Reliever/Fever Reducer
Regular Strength, Contains No Aspirin
See New Warnings
50 Tablets