Label: KROGER NIGHTTIME SLEEP AID CAPLET- diphenhydramine hydrochloride tablet, film coated
- NDC Code(s): 59450-601-01
- Packager: The Kroger Co.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 29, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each caplet)
- Purpose
- Use
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Warnings
Do not use
• in children under 12 years of age
• with any other product containing diphenhydramine, even one used on skinAsk a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate glandAsk a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
• avoid alcoholic drinks
• drowsiness will occur
• do not drive a motor vehicle or operate machineryStop use and ask a doctor if
• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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SPL UNCLASSIFIED SECTION
Compare to the active ingredient of TYLENOL® PM Simply Sleep®*
Does Not Contain Pain Reliever
READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202FOR MORE PRODUCT INFORMATION, SCAN UPC USING YOUR KROGER APP OR CALL 800-632-6900
Product of India
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol® PM Simply Sleep®.
- Packaging
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INGREDIENTS AND APPEARANCE
KROGER NIGHTTIME SLEEP AID CAPLET
diphenhydramine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59450-601 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 Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape OVAL (Oblong) Size 11mm Flavor Imprint Code DB Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59450-601-01 1 in 1 CARTON 02/01/2024 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M010 02/01/2024 Labeler - The Kroger Co. (006999528)