Label: REVASOL SLEEP AID- diphenhydramine hcl liquid
- NDC Code(s): 84379-284-04
- Packager: Rnv LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 11, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
REVASOL SLEEP AID
diphenhydramine hcl liquidProduct 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)

