ACETAMINOPHEN ORAL SOLUTION liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 160 mg in 5 mL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

ACETAMINOPHEN ORAL SOLUTION- ACETAMINOPHEN LIQUID
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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ACETAMINOPHEN
ORAL SOLUTION USP
ALCOHOL FREE
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH 5 ML TEASPOONFUL)
Acetaminophen 160 mg
PURPOS E
Pain reliever/fever reducer
US ES
temporarily relieves minor aches and pains due to:
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temporarily reduces fever
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if:
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SORE THROAT WARNING
If sore throat is severe, persists for more than 2 days, is
accompanied or followed by fever, headache,
rash, nausea, or vomiting, consult a doctor promptly.
DO NOT USE
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headache
muscular aches
backache
minor pain of arthritis
the common cold
toothache
premenstrual and menstrual cramps
adult takes more than 6 doses in 24 hours, which is the maximum daily
amount
child takes more than 5 doses in 24 hours
adult has 3 or more alcoholic drinks everyday while using this product
with any other drug containing acetaminophen (prescription or
nonprescription). If you are not
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ASK A DOCTOR BEFORE USE IF THE USER HAS liver disease.
ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE USER IS taking the blood
thinning drug warfarin.
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
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 children even if you do not notice
any signs or symptoms.
DIRECTIONS
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AGE
DOS E
adults and children 12 years of age and over
20.3 mL (650 mg) every 4 to 6 hours
not to exceed 6 doses in a 2