Label: KROGER NIGHTTIME SLEEP AID- diphenhydramine hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 30142-116-01 - Packager: KROGER COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 November 23, 2022
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
- WARNINGS
- Ask a doctor before use if you have
- ASK DOCTOR/PHARMACIST
- When using this product
- Stop use and ask a doctor if
- PREGNANCY OR BREAST FEEDING
- SPL UNCLASSIFIED SECTION
- KEEP OUT OF REACH OF CHILDREN
- Overdose warning
- Directions
- Other information
- Inactive ingredients
- QUESTIONS
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PRINCIPAL DISPLAY PANEL
COMPARE TO the active ingredient of SIMPLY SLEEP ® NIGHTTIME SLEEP AID CAPLETS*
Kroger
NDC 30142-116-01
Nighttime Sleep-Aid
Diphenhydramine HCl, 25mg
Does NOT contain Pain Reliever
For a Restful
Night's Sleep
SAFE, NON-HABIT FORMING
100
MINI-CAPLETS
actual size
*Simply Sleep® is a registered trademark of Johnson & Johnson, New Brunswick, NJ 08933-7001. Johnson & Johnson is not affiliated with The Kroger Co. or this product.
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INGREDIENTS AND APPEARANCE
KROGER NIGHTTIME SLEEP AID
diphenhydramine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-116 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape CAPSULE Size 11mm Flavor Imprint Code S5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-116-01 1 in 1 CARTON 04/16/2019 1 100 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 04/16/2019 Labeler - KROGER COMPANY (006999528) Registrant - Spirit Pharmaceuticals LLC (179621011)