Label: DIPHENHYDRAMINE HCL ORAL SOLUTION- diphenhydramine hcl oral solution
- NDC Code(s): 57237-318-01, 57237-318-11
- Packager: Rising Pharma Holdings, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 23, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient per 10 mL (1 Unit Dose)
- Purpose
- Uses
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Warnings
Do not use
• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skinAsk a doctor before use if you have
• a breathing problem such as chronic bronchitis
• glaucoma
• trouble urinating due to enlarged prostate gland - Directions
- Other information
- SPL UNCLASSIFIED SECTION
- NDC Information -
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HCL ORAL SOLUTION
diphenhydramine hcl oral solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57237-318 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) WATER (UNII: 059QF0KO0R) 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:57237-318-11 100 in 1 BOX, UNIT-DOSE 12/15/2023 1 NDC:57237-318-01 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 M 12/15/2023 Labeler - Rising Pharma Holdings, Inc. (116880195)