VICKS ZZZQUIL NIGHT PAIN- diphenhydramine hydrochloride and acetaminophen tablet, coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Preparatomtale Preparatomtale (SPC)
12-10-2023

Aktiv ingrediens:

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

Tilgjengelig fra:

The Procter & Gamble Manufacturing Company

Administreringsrute:

ORAL

Resept typen:

OTC DRUG

Indikasjoner:

Pain reliever Nighttime sleep-aid - for the temporary relief of occasional minor aches and pains with accompanying sleeplessness. 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. - for children under 12 years of age - with any other product containing diphenhydramine, even one used on skin. Stop use and ask a doctor if - pain gets worse or lasts more than 10 days - fever gets worse or lasts more than 3 days - new symptoms occur - sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. These could be signs of a serious condition.

Autorisasjon status:

OTC monograph final

Preparatomtale

                                VICKS ZZZQUIL NIGHT PAIN- DIPHENHYDRAMINE HYDROCHLORIDE AND
ACETAMINOPHEN TABLET, COATED
THE PROCTER & GAMBLE MANUFACTURING COMPANY
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VICKS ZZZQUIL NIGHT PAIN GELTABS
_DRUG FACTS_
ACTIVE INGREDIENTS (IN EACH GELTAB)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
PURPOSE
Pain reliever
Nighttime sleep-aid
USES
for the temporary relief of occasional minor aches and pains with
accompanying
sleeplessness.
WARNINGS
LIVER WARNING:
This product contains acetaminophen. Severe liver damage may occur if
• adult takes more than 4 doses (2 geltabs each) in 24 hrs, which is
the maximum daily
amount for this product
• taken with other drugs containing acetaminophen
• 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
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.
for children under 12 years of age
with any other product containing diphenhydramine, even one used on
skin.
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver disease
a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking the blood thinning drug warfarin
taking sedatives or tranquilizers
WHEN USING THIS PRODUCT
avoid alcoholic beverages
drowsiness will occur
do not drive a motor vehicle or operate machinery
STOP USE AND ASK A DOCTOR IF
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
sleeplessness persists continuously for more than 2 weeks. Insomnia
may be a
symptom of serious underlying medical illness.
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.
In case o
                                
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