Label: LEADER ALLERGY- diphenhydramine hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 37205-270-62, 37205-270-78 - 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 tablet)
- 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
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, DandC Red 27Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, and titanium dioxide
* contains one or more of these ingredients -
Package/Label Principal Display Panel
NDC 63548-0070-1
*Compare to the active ingredient in Benadryl® Allergy Ultratabs®
Antihistamine
Allergy Tablets
Diphenhydramine Hydrochloride 25 mg
For Allergy Relief
Sneezing, Itchy, Watery Eyes, Runny Nose, Itchy Throat
12 Tablets
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 tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-270 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 CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 27 (UNII: 2LRS185U6K) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYVINYL ALCOHOL (UNII: 532B59J990) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PINK (dark) Score no score Shape CAPSULE Size 10mm Flavor Imprint Code T61;V25;EL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-270-62 2 in 1 CARTON 1 12 in 1 BLISTER PACK 2 NDC:37205-270-78 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 05/11/1992 Labeler - Cardinal Health (097537435)