TYLO NIGHT (ACETAMINOPHEN)- acetaminophen tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

America Medic & Science, LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever Night time sleep aid - temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness - 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 have ever had an allergic reaction to this product or any of its ingredients. Stop use and ask a doctor if - sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. - pain gets worse or lasts more than 10 days - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur These could be signs of a serious condition.

Authorization status:

OTC monograph not final

Summary of Product characteristics

TYLO NIGHT (ACETAMINOPHEN)- ACETAMINOPHEN TABLET, DELAYED RELEASE
AMERICA MEDIC & SCIENCE, LLC
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TYLO NIGHT (ACETAMINOPHEN)500 MG
TYLO NIGHT (ACETAMINOPHEN)
500 MG
DRUG FACTS
ACTIVE INGREDIENT
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
PURPOSE
Pain reliever
Night time 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 have ever had an allergic reaction to this product or any of
its ingredients.
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 YOUR 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 drinks
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 serious underlying medical illness.
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
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.
DIRECTIONS
DO NOT TAKE MORE THAN DIRECTED (SEE OVERDOSE WARNING).
ADULTS AND CHILDREN 12 YEARS AND OVER:
take 2 caplets at bedtime
do not take more than 2 caplets of this produ