Label: REST SIMPLY- diphenhydramine hcl tablet, film coated
- NDC Code(s): 64092-012-24
- Packager: GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
- 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 June 13, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- Uses
-
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
- difficulty in urination due to enlargement of the prostate gland
- glaucoma
- for children under 12 years of age
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
HEALTHCARE™
NDC 64092-012-24
*Compare to the active ingredient
in Simply Sleep®Rest Simply
Diphenhydramine Hydrochloride 25 mg
Night Time Sleep Aid
For relief of occasional sleeplessness
• non habit forming
• contains no pain reliever
ACTUAL SIZE
24 CAPLETS
TAMPER EVIDENT: DO NOT
USE IF PACKAGE IS OPENED
OR IF BLISTER UNIT IS TORN,
BROKEN OR SHOWS ANY
SIGNS OF TAMPERING*This product is not manufactured or distributed by Johnson
& Johnson Corporation, owner of the registered trademark
Simply Sleep®.50844 REV1019E36708
Distributed by: Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E., Grand Rapids, MI 49512
www.glwholesale.comHEALTHCARE GUARANTEE
If you are not completely satisfied with this
product, regardless of reason, return your unused
portion to Great Lakes Wholesale for a full refundHealthcare 44-367
-
INGREDIENTS AND APPEARANCE
REST SIMPLY
diphenhydramine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64092-012 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 STARCH, CORN (UNII: O8232NY3SJ) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape OVAL Size 11mm Flavor Imprint Code 44;367 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64092-012-24 2 in 1 CARTON 06/10/2000 09/16/2024 1 12 in 1 BLISTER PACK; 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 06/10/2000 09/16/2024 Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(64092-012) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(64092-012) , pack(64092-012) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(64092-012) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(64092-012) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(64092-012) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(64092-012)