Label: BANOPHEN- diphenhydramine hcl tablet, film coated
- NDC Code(s): 71205-611-20, 71205-611-30, 71205-611-60, 71205-611-90
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0904-5551
- 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 July 1, 2022
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
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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- glaucoma
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- difficulty in urination due to enlargement of the prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
NDC 71205-611-20
Compare to the active ingredient in Benadryl® Allergy ULTRATAB® Tablets*
Banophen
Diphenhydramine HCl
25 mg
Antihistamine / Allergy ReliefRelieves
Sneezing, Runny Nose,
Itchy Throat and
Itchy, Watery EyesActual Size
20 Minitabs
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy ULTRATAB® Tablets.
50844 REV1220M32908Rev. 03/21 M-17 Re-order No. 250050
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USARepackaged by:
PROFICIENT RX LP
Thousand Oaks, CA 91320
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
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INGREDIENTS AND APPEARANCE
BANOPHEN
diphenhydramine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-611(NDC:0904-5551) 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color pink Score no score Shape OVAL Size 11mm Flavor Imprint Code 44;329 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71205-611-20 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/11/2021 2 NDC:71205-611-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/11/2021 3 NDC:71205-611-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/11/2021 4 NDC:71205-611-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/11/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/02/1990 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(71205-611) , RELABEL(71205-611)