Label: SLEEP AID- diphenhydramine hydrochloride tablet
- NDC Code(s): 59970-079-16
- Packager: Navarro Discount Pharmacies,LLC
- 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 tablet)
Diphenhydramine HCL 25mgClose
helps reduce difficulty falling asleepClose
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 accidental overdose get medical help or contact a Poison Control Center right away.
- adults and children 12 years and older:
- Other information
- each tablet contains:calcium 0.2mg
- store at room temperature
- avoid excessive heat (greater than 100°F) or humidity
- Inactive ingredients
FD&C blue no. 2, hydroxypropyl cellulose, hypromellose 2910, lactose anhydrous, microcrystalline cellulose, polyethylene glycol 6000, silicic acid anhydride, sodium starch glycolate, stearic acid, titanium dioxideClose
- Package label
Vida Mia Sleep Aid Original FormulaClose
- INGREDIENTS AND APPEARANCE
diphenhydramine hcl tablet
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59970-079 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 HYDROXYPROPYL CELLULOSE MICROCRYSTALLINE WAX ANHYDROUS LACTOSE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID SILICON DIOXIDE HYPROMELLOSE 2910 (50 MPA.S) POLYETHYLENE GLYCOL 6000 TITANIUM DIOXIDE Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code BD Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59970-079-16 2 in 1 BOX 1 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 02/01/2013 Labeler - Navarro Discount Pharmacies,LLC (094930963)