Diphenhydramine Hydrochloride Tablet
FDA Label NDC 55154-1589

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Diphenhydramine Hydrochloride (NDC 55154-1589). 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

25 mg Tablets

For Hospital Use Only

LI1729 Rev. 10/24

Drug Facts

Gluten Free

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

Distributed By:

Cardinal Health

Dublin, OH 43017

L61501480726

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]

LI1729 Rev. 10/24

Active Ingredient (In Each Tablet)

Diphenhydramine 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 nose
    • ▪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 prostate 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 older

    1 to 2 tablets

    children 6 to under 12 years

    1 tablet

    children under 6 years

    do not use

Other Information

  • ▪each tablet contains: calcium 20 mg
  • ▪store at 20-25°C (68-77°F).
  • ▪Avoid high humidity. Protect from light
  • ▪small tablet size, easy to swallow

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

How Supplied

They are supplied as follows:

Overbagged with 10 tablets per bag, NDC 55154-1589-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Principal Display Panel

NDC 55154-1589-0

DiphenhydrAMINE HCl

TABLETS 25 mg

10 TABLETS

25mg Bag Label (887cabe5 46d0 4f4e 8f5a 2cfdbc157b58 00)

25mg Bag Label (887cabe5 46d0 4f4e 8f5a 2cfdbc157b58 00)

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