Diphenhydramine Hydrochloride Tablet
FDA Label NDC 68094-018

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Precision Dose, Inc. for the product Diphenhydramine Hydrochloride (NDC 68094-018). 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 tablet), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, 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:
Precision Dose, Inc.
South Beloit, IL 61080

Active Ingredient (In Each Tablet)

Diphenhydramine HCl 25 mg

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 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 prostrate gland

Otc - Ask Doctor/Pharmacist

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

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

  • Use as directed per healthcare professional.
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
    • adults and children 12 years and over1 to 2 tablets
    children 6 to under 12 years1 tablet
    children under 6 yearsdo not use

Other Information

  • each tablet contains: calcium 20 mg
  • store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.

Inactive Ingredients

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments

1-800-397-9228

Principal Display Panel - 25 Mg Tablet Blister Pack Carton

PrecisionDose™

diphenhydrAMINE HCl

25 mg Tablets

100 Tablets
(10x10)

Gluten Free

Hospital Use Only
NDC 68094-018-61

Principal Display Panel (25 mg Tablet Blister Pack Carton)

Principal Display Panel (25 mg Tablet Blister Pack Carton)

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