ACETAMINOPHEN suspension

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)

MAH:

Precision Dose, Inc.

administration_route:

ORAL

prescription_type:

OTC DRUG

therapeutic_indication:

Pain reliever/fever reducer temporarily: - reduces fever - relieves minor aches and pains due to: the common cold flu headache sore throat toothache - the common cold - flu - headache - sore throat - toothache

leaflet_short:

NDC 68094-130-58 2.5 mL per unit dose syringe Fifty (50) syringes per shipper NDC 68094-231-58 5 mL per unit dose syringe Fifty (50) syringes per shipper NDC 68094-231-61 5 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-231-62 5 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-330-61 10.15 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-330-62 10.15 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-030-62 20.3 mL per unit dose cup Thirty (30) cups per shipper

authorization_status:

OTC monograph not final

SPC

ACETAMINOPHEN- ACETAMINOPHEN SUSPENSION
PRECISION DOSE, INC.
----------
ACETAMINOPHEN ORAL SUSPENSION
Grape Flavor
80 mg/2.5 mL 160 mg/5 mL 325 mg/10.15 mL
650 mg/20.3 mL
_FOR HOSPITAL USE ONLY_
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH 5 ML)
Acetaminophen 160 mg
PURPOSE
Pain reliever/fever reducer
USES
temporarily:
reduces fever
relieves minor aches and pains due to:
the common cold
flu
headache
sore throat
toothache
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
adult takes more than 4,000 mg of acetaminophen in 24 hours
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this
product
ALLERGY ALERT
Acetaminophen may cause severe skin reactions. Symptoms may include:
skin reddening
blisters
rash
If a skin reaction occurs, stop use and seek medical help right away.
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
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 your child has ever had an allergic reaction to this product or any
of its ingredients
ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS liver disease
ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE USER IS taking the blood
thinning
drug warfarin
WHEN USING THIS PRODUCT DO NOT EXCEED RECOMMENDED DOSE (SEE OVERDOSE
WARNING)
STOP USE AND ASK A DOCTOR IF
pain gets worse or lasts more than 10 days (for adults) or 5 days (for
children)
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present
These could be signs of a serious condition
do not give this product to children for pain of arthritis unless
directed by a doctor
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
OVERDOSE WARNING
In case