Label: SLEEP AID NIGHTTIME- diphenhydramine hcl tablet
- NDC Code(s): 49035-808-10
- Packager: EQUATE (Wal-Mart Stores, Inc.)
- 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 October 20, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- Uses
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Warnings
Do not use
- in children under 12 years of age
- with any other products containing diphenhydramine, even one used on skin
ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
**Compare to the active ingredient in Tylenol® Simply Sleep®†
Nighttime SLEEP-AI
Diphenhydramine HCl, 25 mg
Does not contain pain reliever
Fall asleep fast
Wake up rested
Non habit-forming
Caplets
**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademarks Tylenol® and Simply Sleep®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by: Wal-Mart Stores, Inc.,
Bentonville, AR 72716 © Wal-Mart Stores, Inc.
- Product Label
-
INGREDIENTS AND APPEARANCE
SLEEP AID NIGHTTIME
diphenhydramine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-808 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 CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ALUMINUM OXIDE (UNII: LMI26O6933) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (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 T129;S25 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-808-10 1 in 1 BOX 09/07/2018 07/26/2024 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 final part338 09/07/2018 07/26/2024 Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)