Dye Free Allergy Relief Capsule, Liquid Filled
FDA Label NDC 76162-914

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Dye Free Allergy Relief (NDC 76162-914). 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, active ingredient (in each softgel), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
Topco Associates LLC
Itasca, IL 60143

Active Ingredient (In Each Softgel)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

Otc - Do Not Use

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Otc - Ask Doctor

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

Otc - When Using

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
    • adults & children 12 yrs & over1 to 2 Softgels
    children 6 to under 12 yrs1 Softgel
    children under 6 yrsdo not use

Other Information

  • store between 20-25° C (68-77° F)
  • Avoid high humidity and excessive heat
  • protect from moisture and light

Questions Or Comments?

1-800-373-6981 (toll-free)

Inactive Ingredients

gelatin, glycerin, isopropyl alcohol*, light mineral oil*, polyethylene glycol-400, propylene glycol, povidone, purified water, sorbitol sorbitan solution *may contain this ingredient

Principal Display Panel

TopCare health

Dye-Free
Allergy Relief

Diphenhydramine HCl 25 mg


Relieves

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

    • Diphenhydramine HCl 25 mg
    No artificial flavors
    No synthetic colors
    Gluten free*
    Non-GMO

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* Please review the disclaimer below.