Label: MAXIMUM STRENGTH SLEEP AID- diphenhydramine hcl capsule, gelatin coated
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Contains inactivated NDC Code(s)
NDC Code(s): 30142-672-80, 30142-672-96 - 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)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each softgel)
- Purpose
- Use
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Warnings
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- Directions
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
COMPARE TO the active ingredient of
UNISOM® SLEEPGELS®**NDC 30142-672-80
Kroger®
NIghttime Sleep-Aid
Sleep-Aid Softgels
MAXIMUM STRENGTHDiphenhydramine HCI 50 mg
Helps to reduce difficulty falling asleep
Safe, Non-Habit Forming
2 Bottles (96ct each)
TWO BOTTLES INSIDE
LIQUID FILLED SOFTGELS one softgel per dose
actual size
**Unisom® SleepGels® is a registered trademark
of Chattem, Inc., Chattanooga, TN 37409.
Chattem, Inc., is not affiliated with The Kroger Co.
or this product.
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INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH SLEEP AID
diphenhydramine hcl capsule, gelatin coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-672 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 Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color blue Score no score Shape OVAL (903) Size 13mm Flavor Imprint Code 206 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-672-80 2 in 1 CARTON 08/22/2019 1 96 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:30142-672-96 96 in 1 BOTTLE; Type 0: Not a Combination Product 08/22/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 08/22/2019 Labeler - KROGER COMPANY (006999528)