Diphenhist
FDA Label NDC 42254-184

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Diphenhist (NDC 42254-184). 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 5ml teaspoonful), 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

Active Ingredient (In Each 5Ml Teaspoonful)

Diphenhydramine HCl USP 12.5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies

  • runny nose
  • sneezing
  • itchy, water eyes
  • itchy nose or throat

Otc - Do Not Use

Do not use with any other product containing diphenhydramine, even one used on skin

Otc - Ask Doctor

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Otc - When Using

When using this product

  • you may get very drowsy
  • 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.

Directions

  • take every 4 – 6 hours
  • do not take more than 6 doses in 24 hours
    • adults and children 12 years and over2 - 4 teaspoonfuls
    children 6 to under 12 years1 - 2 teaspoonfuls
    children under 6do not use

Other Information

  • each teaspoonful (5 mL) contains:
    sodium 5 mg
  • store between 20°-25° C (68°-77°F)
  • protect from light. Store in outer carton until contents used

Inactive Ingredients

artificial cherry flavor, citric acid, D&C red #33, FD&C red #40, glycerin, polysorbate 20, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions Or Comments?

call 1-800-645-2158, 9 am - 5pm ET, Monday - Friday

Principal Display Panel

COMPARE TO
ACTIVE INGREDIENT IN
BENADRYL®
ALLERGY LIQUID*

CHILDREN'S ALCOHOL-FREE
ALLERGY MEDICATION

Diphenhist®

ORAL SOLUTION

Diphenydramine HCI, USP

Antihistamine

For Temporary Relief of

Symptoms of Upper

Respiratory Allergies

and Hay Fever

4 fl oz
(118 mL)

Diphenhist (diphenhydramine) 12.5mg/5ml (Eefc47ff Ed87 4f98 9fa2 9cb1a0793ba9 01)

Diphenhist (diphenhydramine) 12.5mg/5ml (Eefc47ff Ed87 4f98 9fa2 9cb1a0793ba9 01)

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