Label: ALLERGY RELIEF DIPHENHYDRAMINE HCL 25 MG ANTIHISTAMINE- diphenhydramine hcl bar, chewable
- NDC Code(s): 70677-1059-1
- Packager: Strategic Sourcing Services LLC
- 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 April 27, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each piece)
- Purpose
- Uses
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Warnings
Do not use
- To make 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
- trouble urinating due to an enlarged prostate gland
- Directions
- SPL UNCLASSIFIED SECTION
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Inactive ingredients:
FD&C Red# 40, flavors, geleol mono and diglycerides, glucose syrup, gum arabic, hydroxypropyl betadex, maltitol solution, neotame, polyethylene glycol 400, povidone K30, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.
- SPL UNCLASSIFIED SECTION
- Principal display Panel-25 mg Bottle label
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF DIPHENHYDRAMINE HCL 25 MG ANTIHISTAMINE
diphenhydramine hcl bar, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1059 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 FD&C RED NO. 40 (UNII: WZB9127XOA) CORN SYRUP (UNII: 9G5L16BK6N) ACACIA (UNII: 5C5403N26O) HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK) GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ) MALTITOL (UNII: D65DG142WK) NEOTAME (UNII: VJ597D52EX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) CARRAGEENAN (UNII: 5C69YCD2YJ) SODIUM CHLORIDE (UNII: 451W47IQ8X) STARCH, CORN (UNII: O8232NY3SJ) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) Product Characteristics Color pink (Light pink to red pink) Score no score Shape RECTANGLE Size 23mm Flavor BERRY (Mixed Berry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1059-1 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/27/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/27/2023 Labeler - Strategic Sourcing Services LLC (116956644) Establishment Name Address ID/FEI Business Operations USpharma Ltd 080664601 manufacture(70677-1059)