MAXIMUM STRENGTH NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Available from:

Healthlife of USA

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Nighttime Sleep-Aid - Relief of occasional sleeplessness - a breathing problem such as asthma, emphysema or chronic bronchitis  - glaucoma  - trouble urinating due to an enlarged prostate gland  - heart disease  - taking sedative or tranquilizers or any other sleep-aid. - sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness

Authorization status:

OTC monograph final

Summary of Product characteristics

MAXIMUM STRENGTH NIGHTTIME SLEEP-AID- DIPHENHYDRAMINE HCL CAPSULE,
LIQUID FILLED
HEALTHLIFE OF USA
_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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MAXIMUM STRENGTH NIGHTTIME SLEEP-AID
DRUG FACTS
Maximum Strength Nighttime Sleep-Aid
PURPOS E
Nighttime Sleep-Aid
ACTIVE INGREDIENT (IN EACH SOFTGEL)
Diphenhydramine HCL 50mg
US ES
Relief of occasional sleeplessness
WARNINS
DO NOT USE
for children under 12 years of age
with any other product containing diphenhydramine, even one used on
skin
with other drugs that cause drowsiness such as antihistamine and
nighttime cold/flu products
ASK A DOCTOR BEFORE USE IF YOU HAVE
a breathing problem such as asthma, emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
heart disease
ASK YOUR DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking sedative or tranquilizers or any other sleep-aid.
WHEN USING THIS PRODUCT
drowsiness will occur
avoid alcoholic beverages and other drugs that cause drowsiness
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating 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
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDERN.
OVERDOSE WARNING:
Taking more than directed can cause serious health problems. In case
of
overdose, get medical help or contact a Poison Control Center
(1-800-222-1222) right away. Quick
medical attention is critical for adults as well as for children even
if you do not notice any sighs or
symptoms.
DIRECTIONS
DO NOT TAKE MORE THAN DIRECTED (SEE OVERDOSAGE WARNING)
ADULTS AND CHILDREN 12 YEARS AND OVER:
Take 1 softgel at bedtime if needed or as directed by a
doctor
CHILDREN UNDER 12 YEARS OF AGE:
Do not use
OTHER