PAIN RELIEF PM NIGHTIME SLEEP AID - acetaminophen,diphenhydramine hcl tablet, coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

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Prenos Lastnosti izdelka (SPC)
15-10-2012

Aktivna sestavina:

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

Dostopno od:

Select Corporation

INN (mednarodno ime):

ACETAMINOPHEN

Sestava:

ACETAMINOPHEN 500 mg

Pot uporabe:

ORAL

Tip zastaranja:

OTC DRUG

Terapevtske indikacije:

Pain Reliever, Nightime Sleep Aid

Status dovoljenje:

OTC monograph not final

Lastnosti izdelka

                                PAIN RELIEF PM NIGHTIME SLEEP AID - ACETAMINOPHEN,DIPHENHYDRAMINE HCL
TABLET,
COATED
SELECT CORPORATION
_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._
----------
ACTIVE INGREDIENT
Active Ingredients Purpose
Acetaminophen 500 mg.......................Pain Reliever/Fever Reducer
Diphenhydramine HCl 25 mg...............Nighttime Sleep Aid
PURPOSE
Pain Reliever, Nightime Sleep Aid
DOSAGE
Directions: Adults and children 12 years of age and older:
Take 2 tablets at bedtime, do not exceed 2 tablets (50 mg) in 24
hours, or as directed by a doctor. Children under 12 years:
Consult a doctor
USAGE
Uses: Temporarily relieves: • occasional headaches with minor
aches and pains • for relief of occasional sleeplessness Temporarily
relieves itchy eyes and runny nose associated with: • common
allergies • hay fever Warnings:
WARNINGS
CHILDREN UNDER 12 YEARS OF AGE:
Do not give to children under 12 years of age.
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur if
you take: • more than 2 tablets in 24 hours • with other drugs
containing acetaminophen (prescription or
nonprescription). Ask a
doctor or pharmacist before using with other drugs if you are not
sure. • 3 or more alcoholic drinks
every day while using this product
Caution: This product will cause drowsiness. • do not drive a motor
vehicle or operate machinery after
use. • avoid alchoholic
beverages while taking this product • do not take this product if
you are taking sedatives or
tranquilizers, without first consulting your
doctor • if sleeplessness persists continuously for more than 2
weeks, consult your doctor. Insomnia
may be a symptom of serious
underlying medical illness.
DO NOT USE: • more than the recommended dose • do not take this
product unless directed by a
doctor, if you have a breathing problem such as emphysema or chronic
bronchitis, or if yo
                                
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