Label: SLEEP AID- diphenhydramine hcl tablet, film coated
- NDC Code(s): 46122-651-62, 46122-651-78
- Packager: Amerisource Bergen
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 22, 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
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- for children under 12 years of age
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
Good
Neighbor
Pharmacy®Compare to Simply
Sleep® active ingredient*NDC 46122-651-62
Sleep Aid
diphenhydramine HCl 25 mg
nighttime sleep aidNon-habit forming
• Helps you fall asleep
• Does not contain pain reliever24 Mini caplets
Actual Size
50844 REV1019A36708
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR
SHOWS ANY SIGNS OF TAMPERINGDistributed By
AmerisourceBergen
1 West First Avenue
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.com*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the
registered trademark Simply Sleep®.Good Neighbor Pharmacy 44-367
-
INGREDIENTS AND APPEARANCE
SLEEP AID
diphenhydramine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-651 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:46122-651-62 2 in 1 CARTON 07/29/2020 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:46122-651-78 1 in 1 CARTON 07/29/2020 2 100 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 07/29/2020 Labeler - Amerisource Bergen (007914906) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(46122-651) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(46122-651) , pack(46122-651) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(46122-651) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(46122-651) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(46122-651) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(46122-651)