Label: AXIM ALLERGY- diphenhydramine hydrochloride capsule, liquid filled
- NDC Code(s): 82706-005-01, 82706-005-02
- Packager: VIVUNT LLC
- 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 September 20, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
Warnings
Do not use
- to make a 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
- Take every 4 to 6 hours, or as directed by a doctor
- Do not take more than 12 Softgels in 24 hours for Adults and do not take more than 6 Softgels for children 6 to 12 years of age in 24 hours.
adults and children 12 years and over 1 or 2 Softgels children 6 to under 12 years 1 Softgel children under 6 years do not use - Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL 24
- PRINCIPAL DISPLAY PANEL 6
-
INGREDIENTS AND APPEARANCE
AXIM ALLERGY
diphenhydramine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82706-005 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 PROPYLPARABEN (UNII: Z8IX2SC1OH) GELATIN (UNII: 2G86QN327L) METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (Transparent) Score no score Shape OVAL Size 22mm Flavor Imprint Code axim Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82706-005-01 2 in 1 CARTON 05/09/2022 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:82706-005-02 3 in 1 CARTON 09/20/2023 2 2 in 1 POUCH; 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 05/09/2022 Labeler - VIVUNT LLC (045829437)