EXTRA STRENGTH PAIN RELIEVER PM- acetaminophen and diphenhydramine hcl tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

现在购买

下载 产品特点 (SPC)
16-02-2021

有效成分:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

可用日期:

CARDINAL HEALTH

INN(国际名称):

ACETAMINOPHEN

组成:

ACETAMINOPHEN 500 mg

给药途径:

ORAL

处方类型:

OTC DRUG

疗效迹象:

Pain reliever Nighttime sleep-aid temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

授权状态:

OTC monograph not final

产品特点

                                EXTRA STRENGTH PAIN RELIEVER PM- ACETAMINOPHEN AND DIPHENHYDRAMINE
HCL TABLET, FILM COATED
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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LEADER 44-235
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
_PURPOSE_
Pain reliever
Nighttime sleep-aid
_USES_
temporary relief of occasional headaches and minor aches and pains
with accompanying
sleeplessness
_WARNINGS_
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur
if you take:
more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
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.
with any other product containing diphenhydramine, even one used on
skin
in children under 12 years of age
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
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking the blood thinning drug warfarin
taking sedatives or tranquilizers
WHEN USING THIS PRODUCT
drowsiness will occur
avoid alcoholic beverages
do not drive a motor vehicle or operate machinery
STOP USE AND ASK A DOCTOR IF
sleeplessness persists continuously for more than 2 weeks. Insomnia
may be a
symptom of a serious underlying medical illness.
new symptoms occur
redness or swelling is present
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH O
                                
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