NDC | 0363-0060-24 |
Set ID | cfb67ead-61f9-4d0f-b2db-792b8df3d148 |
Category | HUMAN OTC DRUG LABEL |
Packager | Walgreen Company |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART338 |
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each liquicap)
- Purpose
- Uses
-
Warnings
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin.
- with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Ask a doctor before use if you have
- a breathing problem such as asthma, emphysema, or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- heart disease
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid
When using this product
- avoid alcoholic beverages and other drugs that cause drowsiness
- drowsiness will occur
- be careful when driving a motor vehicle or operating machinery
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
WAL-SLEEP Z DIPHENHYDRAMINE HCL / SLEEP AID
diphenhydramine hydrochloride capsule, gelatin coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0060 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride 50 mg in 2 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) METHYLPARABEN (UNII: A2I8C7HI9T) polyethylene glycols (UNII: 3WJQ0SDW1A) PROPYLPARABEN (UNII: Z8IX2SC1OH) water (UNII: 059QF0KO0R) sorbitol (UNII: 506T60A25R) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color PURPLE Score no score Shape CAPSULE Size 15mm Flavor Imprint Code R060 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0060-24 24 in 1 CARTON 1 2 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 12/08/2011 Labeler - Walgreen Company (008965063)