Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-9895-48 - Packager: WALGREENS
- 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 December 28, 2020
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Do Not Use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of the reach of children
- Directions
- Other information
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Inactive ingredients
ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, dicalcium phosphate dihydrate, FD&C blue #1, FD&C yellow #6, gelatin, hydroxy propyl cellulose, hypromellose, isopropyl alcohol, lecithin, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, propylene glycol, shellac, talc, titanium dioxide, xanthan gum.
- Questions or comments?
- Diphenhydramine HCl 50mg
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9895 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TALC (UNII: 7SEV7J4R1U) AMMONIA (UNII: 5138Q19F1X) XANTHAN GUM (UNII: TTV12P4NEE) ISOPROPYL ALCOHOL (UNII: ND2M416302) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) D&C RED NO. 33 (UNII: 9DBA0SBB0L) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GELATIN (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) Product Characteristics Color blue, gray Score no score Shape CAPSULE Size 16mm Flavor Imprint Code G16 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9895-48 48 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 07/20/2017 Labeler - WALGREENS (008965063)