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Drug Facts
Axiv Allergy Capsule, Liquid Filled
FDA Label NDC 82706-019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vivunt Pharma Llc for the product Axiv Allergy (NDC 82706-019). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| 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
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
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 children 12 years and over. Do not take more than 6 Softgels for children 6 to under 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.
- Tamper Evident: Do not use if carton or pouch is open
Inactive Ingredients
Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide
Principal Display Panel 24
Compare to Benadryl® Allergy Liqui-Gels®
active ingredients*
NDC 82706-019-01
AXIV Antihistamine
- Runny Nose
- Sneezing
- Itchy, Watery Eyes
- Itchy Throat
DYE-FREE
Diphenhydramine HCl
24 SOFTGELS** **Liquid-filled capsules
Principal Display Panel 6
Compare to Benadryl® Allergy Liqui-Gels®
active ingredients*
NDC 82706-019-02
AXIV Antihistamine
Runny Nose
Sneezing
Itchy, Watery Eyes
Itchy Throat
DYE-FREE
Diphenhydramine HCl
6 SOFTGELS** **Liquid-filled capsules
* Please review the disclaimer below.
