OTC Medication Information: AXIM Allergy

AXIM ALLERGY- diphenhydramine hydrochloride capsule, liquid filled
VIVUNT PHARMA LLC

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 Facts

Active Ingredient (in each softgel) Purpose
Diphenhydramine HCl 25 mg Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
  • runny nose
  • sneezing

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Keep out of reach of children.

If pregnant or breast-feeding

ask a health professional before use.

Overdose Warning

In case of overdose, get medical help or contact a poison control center immediately.

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

  • Store at 20° — 25 °C (68 °- 77 °F)
  • Read all product information before using
  • Tamper Evident: Do not use if the foil printed on the blister is torn or ripped.

Inactive ingredients

Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide

PRINCIPAL DISPLAY PANEL

Compare to Benadryl® Allergy Liqui-Gels®

active ingredients*

NDC 82706-005-01

Antihistamine

  • Runny Nose
  • Sneezing
  • Itchy, Watery Eyes
  • Itchy Throat

DYE-FREE

Diphenhydramine HCl

24 SOFTGELS** **Liquid-filled capsules

*This product is not manufactured or distributed by

Johnson & Johnson Consumer Inc. Benadryl® Allergy Liqui-Gels® are registered trademarks of

Johnson & Johnson Consumer Inc.

Axim Allergy
(click image for full-size original)
AXIM ALLERGY
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:82706-005
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
PROPYLPARABEN
GELATIN
METHYLPARABEN
WATER
GLYCERIN
SORBITOL
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color white (Transparent) Score no score
Shape OVAL Size 22mm
Flavor Imprint Code axim
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82706-005-01 24 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (82706-005-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 05/09/2022
Labeler — VIVUNT PHARMA LLC (045829437)

Revised: 05/2022 VIVUNT PHARMA LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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