Label: ALLERGY RELIEF- diphenhydramine hcl tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 67510-0158-0, 67510-0158-2, 67510-0158-4 - Packager: Kareway Product, Inc.
- 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 February 15, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- If pregnant or breast-feeding,
- Keep out of reach of children.
-
Directions
- take every 4 to 6 hours
- do not take more than 6 doses in 24 hours
adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 tablets) children 6 to under 12 years of age 12.5** to 25 mg (1 tablet) children under 6 years of age ask a doctor **12.5 mg dosage strength is not available in this package. Do not attempt to break tablets.
- Other information
- Inactive ingredients
- Package label
-
INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
diphenhydramine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0158 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 WAX (UNII: XOF597Q3KY) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) CROSPOVIDONE (UNII: 68401960MK) STEARIC ACID (UNII: 4ELV7Z65AP) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSES (UNII: 3NXW29V3WO) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ETHANETHIOL (UNII: M439R54A1D) Product Characteristics Color blue Score no score Shape ROUND Size 9mm Flavor Imprint Code BE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0158-2 2 in 1 BOX 1 12 in 1 BLISTER PACK 2 NDC:67510-0158-4 4 in 1 BOX 2 12 in 1 BLISTER PACK 3 NDC:67510-0158-0 2 in 1 BOX 3 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/18/2011 Labeler - Kareway Product, Inc. (121840057)