Label: SLEEP AID- diphenhydramine hydrochloride tablet
- NDC Code(s): 59779-431-62, 59779-431-78
- Packager: CVS Pharmacy
- 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.
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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
- trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
adults and children 12years 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 15 mg
- store at 20-25°C (68-77°F)
- Inactive ingredients
carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxideClose
- Questions or comments?
- Principal Display Panel
Compare to the active ingredient in Simply Sleep®
DIPHENHYDRAMINE HCl 25 mg
For a restful night's sleep
Safe, non-habit forming
Does not contain pain reliever
Sleep-Aid Carton Image 1
Sleep-Aid Carton Image 2
- INGREDIENTS AND APPEARANCE
diphenhydramine hydrochloride tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-431 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 CARNAUBA WAX (UNII: R12CBM0EIZ) CROSPOVIDONE (UNII: 68401960MK) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (Light Blue) Score no score Shape CAPSULE Size 11mm Flavor Imprint Code L431 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-431-62 2 in 1 CARTON 1 12 in 1 BLISTER PACK 2 NDC:59779-431-78 1 in 1 CARTON 2 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 10/03/2000 Labeler - CVS Pharmacy (062312574)