FDA Label for Diphenhydramine Hcl Oral Solution
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH 5 ML)
- ACTIVE INGREDIENT (IN EACH 10 ML)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- HOW SUPPLIED
- QUESTIONS OR COMMENTS?
- 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 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 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
Principal Display Panel
Delivers 5 mL
NDC 69339-151-05
Diphenydramine HCl Oral Solution, USP
12.5 mg/5 mL
For Institutional Use Only
3 69339 15105 1
Lot # 000000
Exp: MM/YYY
See Insert
DASH Pharmaceuticals LLC
Upper Saddle River, NJ 07458
DASH-
DOSE
Delivers 10 mL
NDC 69339-152-01
Diphenydramine HCl Oral Solution, USP
25 mg/10 mL
For Institutional Use Only
3 69339 15201 0
Lot # 000000
Exp: MM/YYY
See Insert
DASH Pharmaceuticals LLC
Upper Saddle River, NJ 07458
DASH-
DOSE
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