ONLY FOR SLEEP- diphenhydramine hcl tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

O4 Global Trading Usa, Llc

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Nighttime sleep-aid for relief of occasional sleeplessness

Authorization status:

OTC monograph final

Summary of Product characteristics

ONLY FOR SLEEP- DIPHENHYDRAMINE HCL TABLET
O4 GLOBAL TRADING USA, LLC
_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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_ONLY FOR- _SLEEP
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH CAPLET)_
Diphenhydramine HCL 25mg
_PURPOSE_
Nighttime sleep-aid
_USES:_
for 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
glaucoma
trouble urinating due to an enlarged prostate gland
ASK A DOCTOR 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 accidental overdose, get medical help or
contact a Poison Control
Center right away. Prompt medical attention is critical for adults as
well as for children even if you do
not notice any signs or symptoms.
_DIRECTIONS:_
take with a full glass of water
DO NOT TAKE MORE THAN DIRECTED
adults and children 12 years of age and
over
2 caplets at bedtime if needed, or as directed by a
doctor
children under 12 years of age
do not use
_OTHER INFORMATION:_
Store at room temperature between 20-25°C (68-77°F)
Avoid high humidity • Protect from light
_INACTIVE INGREDIENTS:_
Croscarmellose sodium, D&C blue #4 aluminium lake, dibasic calcium
phosphate, hydroxy propyl
methyl cellulose, isopropyl alcohol, magnesium stearate,
microcrystalline cellulose, polyethylene
glycol, talc, titanium dioxide.
_QUESTIONS OR COMMENTS ?_
_1-833-665-