DIPHENHYDRAMINE HCL liquid

Diphenhydramine HCl by

Drug Labeling and Warnings

Diphenhydramine HCl by is a Otc medication manufactured, distributed, or labeled by BI-MART, Rnv LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each 30 mL dose cup) 

Diphenhydramine HCl 50mg

Purpose

Nightime sleep-aid

Uses

for the 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 emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

 taking sedatives or tranquilizers

When using this product

avoid alcoholic beverages

Stop use and ask a doctor if

sleeplessness persists continuosly for more than 2 weeks. Insomnia may be a symptom of serious underlying medical ilness.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

take only one dose (30 mL) per day (24 hours)
only use dose cup provided

• Age: Dose
• adults and children 12 years and over: 30 mL at bedtime if needed or as directed by a doctor
• children under 12 years: do not use

Other information

each 30 mL dose cup contains:sodium 24 mg
store between 15-30°C (59-86°F).

Inactive ingredients

anhydrous citric acid, FD&C Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose.

Questions or comments?

1-844-912-4012

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37835-519
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HCL (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HCL	50 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37835-519-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	05/01/2025

Labeler - BI-MART (027630078)

Registrant - BI-MART (027630078)

Establishment
Name	Address	ID/FEI	Business Operations
Rnv LLC		118917568	manufacture(37835-519)