Label: NIGHTTIME SLEEP-AID - diphenhydramine hydrochloride tablet
- NDC Code(s): 57896-785-72
- Packager: Geri-Care Pharmaceutical Corp
- 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 Hydrochloride 25mgClose
- relieves occasional sleeplessness
Do not use
• in children under 12 years
• with any other product containing diphenhydramine, including one used
Ask a doctor before use if you have
• a breathing problem such as emphysema, asthma, or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
• avoid alcoholic beverages
• drowsiness will occur
• avoid driving a motor vehicle or operating machinery
Stop use and ask a doctor if • sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
• adults and children 12 years and over: take two caplets at bedtime if needed, or as directed by a doctor
• do not exceed recommended doseClose
- Other information
- each caplet contains: calcium 85mg
- store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
- Inactive ingredients
calcium phosphate, croscarmellose sodium, magnesium stearate,
microcrystalline cellulose, silica.Close
- package label
the sensible choice for price and health
with Diphenhydramine HCl
25 mg each
Compare to active ingredient in Nytol
- INGREDIENTS AND APPEARANCE
diphenhydramine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-785 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape CAPSULE Size 15mm Flavor Imprint Code 93XF;57344 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-785-72 72 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 01/01/2004 Labeler - Geri-Care Pharmaceutical Corp (611196254) Registrant - Geri-Care Pharmaceutical Corp (611196254)