REVASOL SLEEP AID- diphenhydramine hcl liquid

REVASOL SLEEP AID by

Drug Labeling and Warnings

REVASOL SLEEP AID by is a Otc medication manufactured, distributed, or labeled by Rnv LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each 30 mL dose cup) Purpose
Diphenhydramine HCl 50mg.................................................... Nightime sleep-aid

PURPOSE

Nightime sleep-aid

INDICATIONS & USAGE

Uses
for the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

WARNINGS

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 DOCTOR

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking sedatives or
tranquilizers

WHEN USING

When using this product
avoid alcoholic beverages

STOP USE

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information
each 30 mL dose cup contains: sodium 4 mg
store between 15-30°C (59-86°F).
TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or
missing.

INACTIVE INGREDIENT

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

Questions or comments 1-888-446-4753
Monday - Friday (9 AM - 5 PM EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REVASOL SLEEP AID 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84379-284
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		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84379-284-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	02/03/2025

Labeler - Rnv LLC (118917568)

Registrant - Rnv LLC (118917568)

Establishment
Name	Address	ID/FEI	Business Operations
Rnv LLC		118917568	manufacture(84379-284)