DIPHENHYDRAMINE HCL ORAL SOLUTION- diphenhydramine hydrochloride solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
01-11-2023

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Natco Pharma USA LLC

Njia ya uendeshaji:

ORAL

Dawa ya aina:

OTC DRUG

Matibabu dalili:

Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy throat

Bidhaa muhtasari:

Each 5 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 12.5mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms: NDC 69339-151-05             (1) unit dose cup                         5mL NDC 69339-151-17             40 (4x10) unit dose cups            5mL NDC 69339-151-19             100 (10x10) unit dose cups        5mL Each 10 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 25mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms: NDC 69339-152-01             (1) unit dose cup                         10mL NDC 69339-152-17             40 (4x10) unit dose cups            10mL NDC 69339-152-19             100 (10x10) unit dose cups        10mL

Idhini hali ya:

OTC monograph final

Tabia za bidhaa

                                DIPHENHYDRAMINE HCL ORAL SOLUTION- DIPHENHYDRAMINE
HYDROCHLORIDE SOLUTION
NATCO PHARMA USA LLC
----------
DIPHENYDRAMINE HCL ORAL SOLUTION, USP
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH 5 ML)
Diphenhydramine HCl USP 12.5 mg
ACTIVE INGREDIENT (IN EACH 10 ML)
Diphenhydramine HCl USP 25 mg
PURPOSE
Antihistamine
USES
temporarily relieves these symptoms due to hay fever or other upper
respiratory
allergies: • runny nose • sneezing • itchy, watery eyes •
itchy throat
WARNINGS
DO NOT USE
• in neonates or premature infants • if pregnant or breast-feeding
• if hypersensitive to
diphenhydramine HCI and other similar antihistamine • with any other
product
containing diphenhydramine, even one used on skin • to make a child
sleepy
ASK A DOCTOR BEFORE USE IF YOU HAVE
• glaucoma • a breathing problem such as emphysema or chronic
bronchitis
• a sodium restricted diet • trouble urinating due to enlarged
prostate gland
ASK A DOCTOR OR PHARMACIST BEFORE USE if you are taking tranquilizers
or sedatives
WHEN USING THIS PRODUCT
• marked drowsiness may occur • avoid alcoholic drinks •
alcohol, sedatives, and
tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery •
excitability may
occur, especially in children
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center right away (1-
800-222-1222)
DIRECTIONS
• Use the following dosage guidelines when using this product
AGE (YR)
DOSE (ML)
Adults and children
12
years and older
take 10 mL every 4
to 6 hours; not more
than 60 mL
in 24 hours.
Children 6 years to
under
12 years
take 5 mL every 4 to
6 hours; not more
than 30 mL
in 24 hours
Children under 6
years
ask a doctor
OTHER INFORMATION
• each 5mL contains sodium 10mg
• each 10mL contains sodium 20mg
• alcohol free, cherry flavor
• store at 20-25°C (68-77°F)
• protect from excessive moisture
• do not use if lid seal is open or damaged
• see top of cup for lot number and expiration date
INACTIVE
                                
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