Label: DIPHENHYDRAMINE HCL capsule
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NDC Code(s):
71335-0526-0,
71335-0526-1,
71335-0526-2,
71335-0526-3, view more71335-0526-4, 71335-0526-5, 71335-0526-6, 71335-0526-7, 71335-0526-8, 71335-0526-9
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 66424-021
- Category: HUMAN OTC DRUG LABEL
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 January 6, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(in each capsule)
- Uses:
- Warnings:
- Do not use
- Ask a doctor or pharmacist before use
- When using this product
- If pregnant or breast-feeding,
- Keep out of reach of children
- Directions:
- Other information:
- Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate
- Questions? Adverse drug event call:
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HOW SUPPLIED
Product: 71335-0526
NDC: 71335-0526-1 15 CAPSULE in a BOTTLE
NDC: 71335-0526-2 20 CAPSULE in a BOTTLE
NDC: 71335-0526-3 30 CAPSULE in a BOTTLE
NDC: 71335-0526-4 10 CAPSULE in a BOTTLE
NDC: 71335-0526-5 6 CAPSULE in a BOTTLE
NDC: 71335-0526-6 100 CAPSULE in a BOTTLE
NDC: 71335-0526-7 90 CAPSULE in a BOTTLE
NDC: 71335-0526-8 60 CAPSULE in a BOTTLE
NDC: 71335-0526-9 2 CAPSULE in a BOTTLE
NDC: 71335-0526-0 12 CAPSULE in a BOTTLE
- Diphenhydramine 50mg Capsule
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HCL
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-0526(NDC:66424-021) 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color pink Score no score Shape CAPSULE Size 14mm Flavor Imprint Code PH013 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71335-0526-1 15 in 1 BOTTLE; Type 0: Not a Combination Product 01/27/2010 2 NDC:71335-0526-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 01/27/2010 3 NDC:71335-0526-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/27/2010 4 NDC:71335-0526-4 10 in 1 BOTTLE; Type 0: Not a Combination Product 01/27/2010 5 NDC:71335-0526-5 6 in 1 BOTTLE; Type 0: Not a Combination Product 01/27/2010 6 NDC:71335-0526-6 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/27/2010 7 NDC:71335-0526-7 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/27/2010 8 NDC:71335-0526-8 60 in 1 BOTTLE; Type 0: Not a Combination Product 01/27/2010 9 NDC:71335-0526-9 2 in 1 BOTTLE; Type 0: Not a Combination Product 01/27/2010 10 NDC:71335-0526-0 12 in 1 BOTTLE; Type 0: Not a Combination Product 01/27/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/27/2010 Labeler - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-0526) , RELABEL(71335-0526)