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  5. Label Information: Diphenhydramine Hcl Oral Solution

FDA Label for Diphenhydramine Hcl Oral Solution

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 5 ML)
    3. ACTIVE INGREDIENT (IN EACH 10 ML)
    4. PURPOSE
    5. USES
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - ASK DOCTOR/PHARMACIST
    9. WHEN USING THIS PRODUCT
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. HOW SUPPLIED
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Diphenhydramine Hcl Oral Solution Product Label

The following document was submitted to the FDA by the labeler of this product Natco Pharma Usa Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



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


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


Otc - Ask Doctor/Pharmacist



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


Otc - Keep Out Of Reach Of 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 yearsask 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 Ingredients



Citric acid, D&C Red No. 33, FD&C Red No. 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate,
and sucrose.


How Supplied



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


Questions Or Comments?



Call 201-786-6500

Dash Pharmaceuticals LLC
Upper Saddle River, NJ 07458

DP-UD-PI-AT-[117894] Rev 08/20


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