Label: SLEEP AID DYE-FREE NIGHTTIME- diphenhydramine hcl tablet, film coated
- NDC Code(s): 0363-0627-12
- 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.
Updated May 31, 2016
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- Active ingredient (in each caplet)
Diphenhydramine HCl 25 mgClose
for relief of occasional sleeplessnessClose
Do not use
- in 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
When using this product
- drowsiness will occur
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- do not take more than directed
- adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
- children under 12 years: do not use
- Other information
- each caplet contains: calcium 28 mg
- see end flap for expiration date and lot number
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- Inactive ingredients
corn starch, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talcClose
- Questions or comments?
- Principal Display Panel
WALGREENS PHARMACIST RECOMMENDED⧧
DYE-FREE • NIGHTTIME
Diphenhydramine HCl 25 mg /
Nighttime Sleep Aid
• For a restful night's sleep
• Does not contain pain reliever
• Safe, non-habit forming
Compare to Simply Sleep®
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
⧧Walgreens Pharmacist Survey Study,
⧧⧧This product is not manufactured
or distributed by McNeil Consumer
Healthcare, owner of the registered
trademark Simply Sleep®.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2016 Walgreen Co.
- INGREDIENTS AND APPEARANCE
SLEEP AID DYE-FREE NIGHTTIME
diphenhydramine hcl tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0627 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) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) Product Characteristics Color WHITE Score no score Shape OVAL Size 11mm Flavor Imprint Code 44;627 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0627-12 1 in 1 CARTON 07/01/2013 1 100 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 FINAL part338 07/01/2013 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(0363-0627) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(0363-0627)