Allergy
FDA Label NDC 70005-036

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by We Care Distributors Inc. for the product Allergy (NDC 70005-036). 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 active ingredient (in each 5 ml)*, 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, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 5 Ml)*

Diphenhydramine HCl 12.5 mg

*5 mL = 1 teaspoon (tsp)

Purpose

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 common cold:
  • runny nose
  • sneezing

Do Not Use

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

Ask A Doctor Before Use If You Have

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

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 or tranquilizers may increase drowsiness
  • be careful when operating 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 right away. (1-800-222-1222)

Directions

  • take every 4 - 6 hours
  • do not take more than 6 times in 24 hours

    • Age (yr)

    Dose

    Adult and children 12

    years of age and over

    10-20 mL

    (25 to 50 mg)

    Children 6 to under

    12 years of age

    5-10 mL

    (12.5 to 25 mg)

    Children under 6 years

    of age

    Ask a doctor

Other Information

  • store at room temperature 15-30°C (59-86°F)
  • protect from freezing
  • protect from light
  • each teaspoon (5 mL) contains: sodium 16 mg

Inactive Ingredients

citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium sacchrin, sorbitol, sucrose

Principal Display Panel

Compare to the active ingredient in Children’s Benadryl® Allergy Liquid

See New Warnings and Directions

CHILDREN'S ALLERGY

LIQUID MEDICATION

DIPHENHYDRAMINE HCl

ORAL SOLUTION

ANTIHISTAMINE

Relieves: Sneezing, Runny nose, Itchy, watery eyes, Itchy throat

Cherry Flavored

Alcohol Free

* Please review the disclaimer below.