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 carton is open or blister unit is broken

Inactive ingredients

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

PRODUCT OF INDIA

Distributed by:

VIVUNT PHARMA LLC

8950 SW 74th Court, Suite 1901

Miami Florida Z.C. 33156-3178

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., owner of the registered trademarks Benadryl® Allergy Liqui-Gels®.

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 2 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: 09/2022 VIVUNT PHARMA LLC