Label: WAL-SLEEP Z DIPHENHYDRAMINE HCL / SLEEP AID- diphenhydramine hydrochloride capsule, gelatin coated
-
Contains inactivated NDC Code(s)
NDC Code(s): 0363-0060-24 - Packager: Walgreen 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 December 3, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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)