Label: NIGHTTIME SLEEP-AID- diphenhydramine hcl tablet
- NDC Code(s): 80136-785-96
- Packager: NORTHEAST PHARMA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 26, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- Uses
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Warnings
Do not use
• in children under 12 years
• with any other product containing diphenhydramine, including one used
on skin
Ask a doctor before use if you have
• a breathing problem such as emphysema, asthma, or chronic bronchitis
• glaucoma
• 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
• do not drive a motor vehicle or operate 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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- package label
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INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP-AID
diphenhydramine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80136-785 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 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:80136-785-96 96 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M010 09/01/2021 Labeler - NORTHEAST PHARMA (081232935) Registrant - Geri-Care Pharmaceutical Corp (611196254)