Label: ALLERGY RELIEF DIPHENHYDRAMINE HCI, 25 MG ANTIHISTAMINE- diphenhydramine hcl bar, chewable
- NDC Code(s): 70000-0590-1
- Packager: CARDINAL HEALTH
- 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 December 6, 2021
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 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
- Inactive ingredients:
- SPL UNCLASSIFIED SECTION
- Principal display Panel-25 mg carton label
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF DIPHENHYDRAMINE HCI, 25 MG ANTIHISTAMINE
diphenhydramine hcl bar, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0590 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) CORN SYRUP (UNII: 9G5L16BK6N) HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTITOL (UNII: D65DG142WK) MALTODEXTRIN (UNII: 7CVR7L4A2D) NEOTAME (UNII: VJ597D52EX) 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 BUBBLE GUM Imprint Code o Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0590-1 1 in 1 CARTON 12/06/2021 1 10 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 final part341 12/06/2021 Labeler - CARDINAL HEALTH (063997360) Establishment Name Address ID/FEI Business Operations USpharma Ltd 080664601 manufacture(70000-0590) , pack(70000-0590)