Label: BANOPHEN- diphenhydramine hcl tablet, film coated
- NDC Code(s): 0904-5551-24, 0904-5551-59
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 7, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
Warnings
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
MAJOR®
NDC 0904-5551-24
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
24 Minitabs
*This product is not manufactured or distributed by Johnson & Johnson Corporation,
owner of the registered trademark Benadryl® Allergy ULTRATAB® Tablets.
50844 REV0721N32908Rev. 09/21 M-17 Re-order No. 250050
Distributed by:
MAJOR® PHARMACEUTICALS
Livonia, MI 48152
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
Major 44-329
-
INGREDIENTS AND APPEARANCE
BANOPHEN
diphenhydramine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) 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 STARCH, CORN (UNII: O8232NY3SJ) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:0904-5551-24 2 in 1 CARTON 03/02/1990 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0904-5551-59 1 in 1 CARTON 03/02/1990 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 03/02/1990 Labeler - Major Pharmaceuticals (191427277) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(0904-5551) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(0904-5551) , pack(0904-5551) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(0904-5551) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(0904-5551) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(0904-5551)