8 HOUR PAIN RELIEF acetaminophen tablet film coated extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

CVS Pharmacy

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 650 mg

Prescription type:

OTC DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

                                8 HOUR PAIN RELIEF- ACETAMINOPHEN TABLET, FILM COATED, EXTENDED
RELEASE
CVS PHARMACY
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CVS PHARMACY, INC. PAIN RELIEF DRUG FACTS
ACTIVE INGREDIENT (IN EACH CAPLET)
Acetaminophen 650 mg
PURPOS E
Pain reliever/fever reducer
US ES
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WARNINGS
Liver warning: This product contains acetaminophen. Severe liver
damage may occur if you take
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Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms
may include:
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If a skin reaction occurs, stop use and seek medical help right away.
DO NOT USE
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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.
temporarily relieves minor aches and pains due to:
muscular aches
backache
headache
minor pain of arthritis
temporarily reduces fever
more than 6 caplets 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
skin reddening
blisters
rash
with any other drug containing acetaminophen (prescription or
nonprescription). If you are not
sure whether a drug contains acetaminophen, ask a doctor or
pharmacist.
if you are allergic to acetaminophen or any of the inactive
ingredients in this product
STOP USE AND ASK A DOCTOR IF
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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: 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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adults and children 12 years and
over
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children under 12 years
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OTHER INFORMATION
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INACTIVE INGREDIENTS
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C
red #40 aluminum lake,
hypromellose, magnesium stearate, maltodextrin, microcrystalline
cellulose, polyethylene glycol,
                                
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