Label: NIGHTTIME SLEEP AID- diphenhydramine hcl tablet, film coated
- NDC Code(s): 41163-367-06, 41163-367-08, 41163-367-12
- Packager: United Natural Foods, Inc. dba UNFI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 27, 2023
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- 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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
compare to
Simply Sleep®
active ingredient*
NDC 41163-367-12EQUALINE®
nighttime
sleep aid
diphenhydramine HCl 25 mg
(nighttime sleep aid)• safe, effective & non-habit forming
• helps you fall sleep
• not for treating pain, cold or fluactual size
100 mini caplets
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DOES NOT CONTAIN GLUTEN 50844 REV1019C36712
*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Simply Sleep®.DISTRIBUTED BY UNFI
PROVIDENCE, RI 02908 USA
855-423-2630100% Quality
GUARANTEEDEqualine 44-367
-
INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP AID
diphenhydramine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-367 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:41163-367-08 2 in 1 CARTON 06/10/2000 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:41163-367-12 1 in 1 CARTON 06/10/2000 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:41163-367-06 1 in 1 CARTON 06/10/2000 3 200 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 06/10/2000 Labeler - United Natural Foods, Inc. dba UNFI (943556183) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(41163-367) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(41163-367) , pack(41163-367) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(41163-367) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(41163-367) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(41163-367) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(41163-367)