SLEEP AID- diphenhydramine hydrochloride tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

THIRTY MADISON INC

Administreringsrute:

ORAL

Resept typen:

OTC DRUG

Indikasjoner:

Nighttime sleep-aid for relief of occasional sleeplessness

Autorisasjon status:

OTC monograph final

Preparatomtale

SLEEP AID- DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED
THIRTY MADISON 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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THIRTY MADISON INC SLEEP AID DRUG FACTS
ACTIVE INGREDIENT (IN EACH CAPLET)
Diphenhydramine HCl 25 mg
PURPOSE
Nighttime sleep-aid
USE
for relief of occasional sleeplessness
WARNINGS
DO NOT USE
•
•
ASK A DOCTOR BEFORE USE IF YOU HAVE
•
•
•
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking sedatives or tranquilizers
WHEN USING THIS PRODUCT
•
•
•
STOP USE AND ASK A DOCTOR IF
•
in children under 12 years of age
with any other product containing diphenhydramine, even one used on
skin
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma
avoid alcoholic drinks
drowsiness may occur
do not drive a motor vehicle or operate machinery
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 (1-800-222-1222).
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
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•
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INACTIVE INGREDIENTS
carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C
blue #1
aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium
stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80,
pregelatinized starch,
stearic acid, titanium dioxide
QUESTIONS OR COMMENTS?
1-800-719-9260
PRINCIPAL DISPLAY PANEL
Non-habit forming
River
Sleep Aid
DIPHENHYDRAMINE HCl 25 mg
Nighttime Sleep Aid
24 CAPLETS
Does not contain pain reliever
Helps you fall asleep
Co