Label: SLEEP AID NIGHTTIME- diphenhydramine hcl tablet, film coated
- NDC Code(s): 55319-367-08, 55319-367-12
- Packager: Family Dollar Services Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 10, 2024
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- 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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
FAMILY
wellness™*COMPARE TO THE
ACTIVE INGREDIENT
IN SIMPLY SLEEP®SLEEP AID
Diphenhydramine HCl 25 mg
Nighttime Sleep-AidSafe & Effective
Helps You Fall Asleep
Not for treating Pain, Cold or Flu24 CAPLETS
ACTUAL SIZE
NDC 55319-367-08
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 Kenvue
Inc., owner of the registered trademark Simply Sleep®.
50844 ORG101936712DISTRIBUTED BY: MIDWOOD BRANDS LLC,
500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA
NOT 100% SATISFIED?
Return within 30 days to the store of purchase
for a refund (with receipt) or exchange.Family Wellness 44-367
-
INGREDIENTS AND APPEARANCE
SLEEP AID NIGHTTIME
diphenhydramine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-367 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:55319-367-08 2 in 1 CARTON 06/10/2000 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:55319-367-12 1 in 1 CARTON 06/10/2000 2 100 in 1 BOTTLE; 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 - Family Dollar Services Inc (024472631) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(55319-367) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(55319-367) , pack(55319-367) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(55319-367) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(55319-367) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(55319-367) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(55319-367)