Label: GOOD SENSE SLEEP TIME- diphenhydramine hcl capsule, liquid filled
- NDC Code(s): 0113-0052-53, 0113-0052-62, 0113-0052-67
- Packager: L. Perrigo Company
- 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 May 21, 2019
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 softgel)
- 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 an enlargement of the prostate gland
- Keep out of reach of children.
- Directions
- Inactive ingredients
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
GOOD SENSE SLEEP TIME
diphenhydramine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0052 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color PURPLE Score no score Shape OVAL Size 15mm Flavor Imprint Code 052 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0113-0052-53 6 in 1 CARTON 02/06/2014 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0113-0052-62 12 in 1 CARTON 02/06/2014 2 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0113-0052-67 24 in 1 CARTON 05/13/2019 3 2 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 02/06/2014 Labeler - L. Perrigo Company (006013346)