DIPHENHYDRAMINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pharmacy Value Alliance, LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Nighttime sleep-aid ■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep. ■ 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 antihistamines and nighttime cold/flu products ■ a breathing problem such as asthma, emphysema, or chronic bronchitis ■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland ■ heart disease ■ taking sedatives or tranquilizers or any other sleep-aid sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Authorization status:

OTC monograph final

Summary of Product characteristics

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE HYDROCHLORIDE TABLET
PHARMACY VALUE ALLIANCE, 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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_SLEEP-AID_
DIPHENHYDRAMINE HCL USP, 25 MG
NIGHTTIME SLEEP AID
ACTIVE INGREDIENT
(in each gelcap)
Diphenhydramine HCl USP, 25 mg
PURPOS E
Nighttime sleep-aid
US ES
■ for relief of occasional sleeplessness
■ reduces time to fall asleep if you have difficulty falling asleep.
WARNINGS
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 antihistamines and
nighttime cold/flu products
ASK A DOCTOR BEFORE USE IF YOU HAVE
■ a breathing problem such as asthma, emphysema, or chronic
bronchitis
■ glaucoma
■ difficulty in urination due to enlargement of the prostate gland
■ heart disease
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
■ taking sedatives or tranquilizers or any other sleep-aid
WHEN USING THIS PRODUCT
■ avoid alcoholic beverages and other drugs that cause drowsiness
■ drowsiness will occur
■ 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 serious
underlying medical illness.
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
OVERDOSE WARNING:
Taking more than directed can cause serious health problems. In case
of overdose, get medical help or
contact a Poison Control Center right away.
DIRECTIONS
TAKE ONLY ONE DOSE PER DAY (24 HOURS) SEE OVERDOSE WARNING
adults & children 12 years and over
2 gelcaps at bedtime if needed or as directed by a doctor
OTHER INFORMATION
■ store at 20°-25°C (68°-77°F). See USP Controlled Temperature.
■ avoid high hu