HEADACHE PM ASPIRIN FREE- acetaminophen and diphenhydramine citrate tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Disponible depuis:

GREENBRIER INTERNATIONAL, INC.

DCI (Dénomination commune internationale):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 500 mg

Mode d'administration:

ORAL

Type d'ordonnance:

OTC DRUG

indications thérapeutiques:

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

Statut de autorisation:

OTC monograph not final

Résumé des caractéristiques du produit

HEADACHE PM ASPIRIN FREE- ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE
TABLET, FILM
COATED
GREENBRIER INTERNATIONAL, INC.
_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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ASSURED 44-373-DELISTED
_ACTIVE INGREDIENTS (IN EACH TABLET)_
Acetaminophen 500 mg
Diphenhydramine citrate 38 mg
_PURPOSE_
Pain reliever
Nighttime sleep-aid
_USES_
for the 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 2 tablets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
DO NOT USE
if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or
nonprescription). If you are not sure
whether a drug contains acetaminophen, ask a doctor or pharmacist.
in 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
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 may occur
avoid alcoholic beverages
be careful when driving a motor vehicle or operating machinery
STOP USE AND ASK A DOCTOR IF
sleeplessness lasts continuously for more than 2 weeks. Insomnia may
be a symptom of a serious
underlying medical illness.
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
painful area is red or swollen
These could be signs of a serious condition.
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT O