Label: PHARBEDRYL- diphenhydramine hcl capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 67046-006-30 - Packager: Contract Pharmacy Services-PA
- This is a repackaged label.
- Source NDC Code(s): 16103-347
- 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 September 11, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(in each banded capsule)
- Uses:
- Warnings:
- Do not use
- Ask a doctor before use if you have
- 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:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PHARBEDRYL
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67046-006(NDC:16103-347) 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 (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:67046-006-30 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/11/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/11/2006 Labeler - Contract Pharmacy Services-PA (945429777) Establishment Name Address ID/FEI Business Operations Coupler Enterprises 945429777 repack(67046-006)