Label: SLEEP AID DYE-FREE NIGHTTIME- diphenhydramine hydrochloride tablet, film coated
- NDC Code(s): 0363-0627-12
- Packager: WALGREEN CO.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated March 24, 2015
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- Active ingredient (in each caplet)
Diphenhydramine HCl 25 mgClose
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
- trouble urinating due to an enlarged prostate gland
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- 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.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
- do not take more than directed (see overdose warning)
- 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
- 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
Well at Walgreens
WALGREENS PHARMACIST RECOMMENDED⧧
DYE-FREE • NIGHTTIME
Diphenhydramine HCl 25 mg
- For a restful night's sleep
- Does not contain pain reliever
- Safe, non-habit forming
100 MINI CAPLETS
Compare to Simply Sleep® active ingredient⧧⧧
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
⧧Walgreens Pharmacist Survey Study, November 2012.
⧧⧧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 ©2013 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 DEA Schedule 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) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) 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 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 CO. (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)