Label: TOPCARE ZZZ SLEEP- diphenhydramine hcl solution
- NDC Code(s): 36800-200-30, 36800-200-34, 36800-200-40, 36800-200-50
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 6, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each 30 mL)
- Purpose
- Uses
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Warnings
Do not use
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- for children under 12 years of age
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- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
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- a breathing problem such as emphysema or chronic bronchitis
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- glaucoma
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- difficulty in urination due to enlargement of the prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
TOPCARE ZZZ SLEEP
diphenhydramine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-200 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLOXAMER 407 (UNII: TUF2IVW3M2) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) 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:36800-200-30 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/23/2013 2 NDC:36800-200-40 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/20/2013 3 NDC:36800-200-34 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/19/2013 09/30/2020 4 NDC:36800-200-50 2 in 1 PACKAGE 08/20/2013 4 355 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 08/20/2013 Labeler - Topco Associates LLC (006935977)