Label: LEADER ALLERGY- diphenhydramine hydrochloride capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 37205-277-62, 37205-277-78 - Packager: Cardinal Health
- 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 June 28, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Uses
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Warnings
Do not use
- 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 an enlargement of the prostate gland
- with any other product containing diphenhydramine, even one used on skin.
- Directions
- Other information
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Inactive ingredients
DandC Red No. 28, FDandC Blue No. 1, FDandC Red No. 40, gelatin, lactose, and starch.
Questions or comments?
*This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl Allergy Ultratabs.
Distributed by Cardinal Health
Dublin, OH 43017
www.myleader.com 1-800-200-6313
All leader brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.
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Package/Label Principal Display Panel
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Diphenhydramine Hydrochloride 25 mg
Antihistimine
For Allergy Relief
Runny Nose, Sneezing, Itchy Throat, Itchy, watery eyes
24 Capsules
THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
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INGREDIENTS AND APPEARANCE
LEADER ALLERGY
diphenhydramine hydrochloride capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-277 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 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 (UNII: J2B2A4N98G) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color PINK (clear) , WHITE (clear) , RED (band) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code CPC835 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-277-62 2 in 1 CARTON 1 12 in 1 BLISTER PACK 2 NDC:37205-277-78 1 in 1 CARTON 2 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/15/1990 Labeler - Cardinal Health (097537435)