Label: GOOD NEIGHBOR PHARMACY SLEEP AID- diphenhydramine hydrochloride tablet
- NDC Code(s): 24385-431-26, 24385-431-78
- Packager: Amerisource Bergen
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 25, 2019
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- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- Use
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Warnings
Do not use
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- in children under 12 years of age
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- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
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- a breathing problem such as emphysema or chronic bronchitis
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- trouble urinating due to an enlarged prostate gland
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- glaucoma
When using this product
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- avoid alcoholic drinks
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- drowsiness may occur
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- do not drive a motor vehicle or operate machinery
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
GOOD NEIGHBOR PHARMACY SLEEP AID
diphenhydramine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24385-431 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 CARNAUBA WAX (UNII: R12CBM0EIZ) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) 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:24385-431-26 2 in 1 CARTON 04/14/2001 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:24385-431-78 1 in 1 CARTON 08/21/2007 2 100 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 04/14/2001 Labeler - Amerisource Bergen (007914906)