DIPHENHYDRAMINE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

HIMPRIT PHARMACHEM PVT LTD

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Nighttime sleep aid relief of occasional sleeplessness

Authorization status:

OTC monograph final

Summary of Product characteristics

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE HYDROCHLORIDE TABLET,
FILM
COATED
HIMPRIT PHARMACHEM PVT LTD
_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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DIPHENHYDRAMINE HCL TABLETS 25 MG BLUE
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH CAPLET)
Diphenhydramine HCl 25 mg
PURPOS E
Nighttime sleep aid
US E
relief of occasional sleeplessness
WARNINGS
DO NOT USE
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
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 sedatives or
tranquilizers
WHEN USING THIS PRODUCT
avoid alcoholic drinks
drowsiness will occur
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.
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
OVERDOSE WARNING: In case of overdose get medical help or contact a
Poison Control Center right
away.
DIRECTIONS
adults and children 12 years and over
take 2 caplets at bedtime if needed or
as directed by a doctor
children under 12 years
do not use
OTHER INFORMATION
each caplet contains: CALCIUM 20 MG
store between 20-25°C (68-77°F)
DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN
see side panel for lot number and expiration date
INACTIVE INGREDIENTS
carnauba wax, cellulose, croscarmellose sodium dibasic calcium
phosphate, FD&C blue #1,
hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80,
titanium dioxide
PRINCIPAL DISPLAY PANEL - 25 MG LABEL
DIPHENHYDRAMINE HCL TABLETS 25 MG BLUE
EACH FILM COATED TABLET CONTAINS:
DIPHENHYDRAMINE HCL 25 MG
Lot No
:
Jar No.
:
MFG