Adult Allergy Relief Solution
FDA Label NDC 0363-7100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Adult Allergy Relief (NDC 0363-7100). 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 drug facts, purpose, uses, warnings, ask a doctor before use if you have, when using this product, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient [in each 10 mL]

Diphenhydramine HCl, USP 25 mg

Purpose

Antihistamine

Uses

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

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 chronic bronchitis
  • ▪glaucoma
  • ▪a sodium-restricted diet
  • ▪trouble urinating due to enlarged prostate

    • 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

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

Keep Out Of Reach Of Children

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

Directions

  • ▪measure only with dosing cup provided
  • ▪Keep dosing cup with product
  • ▪mL = milliliter
  • ▪do not take more than 6 doses in 24 hours

    •  Age (yr)

    Dose (mL)

    Adult and children 12 years and older

    10 mL to 20 mL (2 to 4 tsp) every 4 to 6 hrs

    Children under 12 years

    Do not use

Other Information

  • each 10 mL contains: sodium 30 mg
  • store at room temperature. Store in outer carton until contents used
  • do not refrigerate
  • see bottom panel for lot number and expiration date
  • protect from light
  • ask a doctor before use if you have a sodium restricted diet.

Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose

Questions or Comments?

1-866-467-2748

Package Label-Principal Display Panel 4 Fl Oz (118 Ml Bottle)

NDC 0363-7100-04

Dye-Free

AdultAllergyRelief

Diphenhydramine HCl | Antihistamine

For Relief of:

  • Runny nose
  • Itchy, watery eyes
  • Sneezing and Itchy Watery Eyes

    • Sugar Free
    Cherry Flavor

    Naturally and Artificially Flavored

    4 FL OZ (118 mL)

    IMPORTANT: Keep this carton for future reference on full labeling.



    Dye-free Adult's Allergy Relief Diphenydramine HCl (Diphenydramine Fig1)

    Dye-free Adult's Allergy Relief Diphenydramine HCl (Diphenydramine Fig1)






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