DIPHENHYDRAMINE HCL ORAL SOLUTION- diphenhydramine hydrochloride solution

Diphenhydramine HCl Oral Solution by

Drug Labeling and Warnings

Diphenhydramine HCl Oral Solution by is a Otc medication manufactured, distributed, or labeled by Natco Pharma USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL ORAL SOLUTION 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69339-151
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69339-151-17	4 in 1 CASE	12/14/2020
1		10 in 1 TRAY
1	NDC: 69339-151-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 69339-151-19	10 in 1 CASE	12/14/2020
2		10 in 1 TRAY
2	NDC: 69339-151-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/14/2020

DIPHENHYDRAMINE HCL ORAL SOLUTION 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69339-152
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69339-152-17	4 in 1 CASE	12/14/2020
1		10 in 1 TRAY
1	NDC: 69339-152-01	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 69339-152-19	10 in 1 CASE	12/14/2020
2		10 in 1 TRAY
2	NDC: 69339-152-01	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/14/2020

Labeler - Natco Pharma USA LLC (079590418)