Label: CHILDRENS ALLERGY RELIEF- diphenhydramine hcl 12.5mg/5ml solution
- NDC Code(s): 73282-1254-1
- Packager: CalmCo LLC
- This is a repackaged label.
- Source NDC Code(s): 70302-127
- 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 July 24, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each 5mL)
- Purpose
- Uses
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Warnings
Ask a doctor before use if your child has
• a breathing problem such as chronic bronchitis
• glaucoma
• a sodium-restricted dietAsk a doctor or pharmacist before use if the child is
taking sedatives or tranquilizersWhen using this product
• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness
• excitability may occur, especially in children - Directions
- Inactive ingredients
- Other information
- Questions or comments?
- Package- 4ct Pocuh
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INGREDIENTS AND APPEARANCE
CHILDRENS ALLERGY RELIEF
diphenhydramine hcl 12.5mg/5ml solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73282-1254(NDC:70302-127) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength SUCRALOSE (UNII: 96K6UQ3ZD4) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) XANTHAN GUM (UNII: TTV12P4NEE) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73282-1254-1 4 in 1 POUCH 01/01/2022 1 5 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2022 Labeler - CalmCo LLC (079308308) Registrant - CalmCo LLC (079308308)