Diphenhydramine HCl Oral Solution DIPHENHYDRAMINE HCL ORAL MAJOR PHARMACEUTICALS FDA Approved Uses Temporarily relieves these symptoms due to hay fever or other respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient per 5 mL (1 Unit Dose) Diphenhydramine HCl 12.5 mg Active ingredient per 10 mL (1 Unit Dose) Diphenhydramine HCl 25 mg
Inactive Ingredients
Inactive ingredients: citric acid flavor FD&C red#40 methylparaben propylene glycol propylparaben purified water sodium citrate and sucralose
Strengths
5 ml 1 unit 12.5 mg 10 ml 25 mg
Quantities
5 ml 10 ml
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To Hay Fever Or Other Respiratory Allergies Runny Nose Sneezing Itchy Watery Eyes Itching Of The Nose Or Throat
Pill Appearance
Color: red

Identifiers & Packaging

Container Type UNKNOWN
UPC
0309047323418 0309047324668
UNII
TC2D6JAD40
Packaging

PRINCIPAL DISPLAY PANEL MAJOR® NDC 0904-7323-41 Each 5 mL Contains: Diphenhydramine HCL Oral Solution 12.5 mg/5 mL Antihistamine Delivers 5 mL • See insert For Institutional Use Only Cherry Flavor MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 Sugar Free • Alcohol Free 5mLPrincipalDisplay; PRINCIPAL DISPLAY PANEL MAJOR® NDC 0904-7324-66 Each 10 mL Contains: Diphenhydramine HCL Oral Solution 25 mg/10 mL Antihistamine Delivers 10 mL • See insert For Institutional Use Only Cherry Flavor MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 Sugar Free • Alcohol Free 10mLPrincipalDisplay

Package Descriptions
  • PRINCIPAL DISPLAY PANEL MAJOR® NDC 0904-7323-41 Each 5 mL Contains: Diphenhydramine HCL Oral Solution 12.5 mg/5 mL Antihistamine Delivers 5 mL • See insert For Institutional Use Only Cherry Flavor MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 Sugar Free • Alcohol Free 5mLPrincipalDisplay
  • PRINCIPAL DISPLAY PANEL MAJOR® NDC 0904-7324-66 Each 10 mL Contains: Diphenhydramine HCL Oral Solution 25 mg/10 mL Antihistamine Delivers 10 mL • See insert For Institutional Use Only Cherry Flavor MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 Sugar Free • Alcohol Free 10mLPrincipalDisplay

Overview

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

Indications & Usage

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

Dosage & Administration

Directions For the 5 mL Unit-Dose: • take every 4 to 6 hours, or as directed by a physician • do not take more than 6 doses in 24 hours age dose Children under 2 years of age Do not use Children 2 to under 6 years of age Do not use unless directed by a doctor Children 6 to under 12 years of age 5 mL (12.5 mg) to 10 mL (25 mg) Directions For the 10 mL Unit-Dose: • take every 4 to 6 hours, or as directed by a physician • do not take more than 6 doses in 24 hours age dose Children under 6 years of age Do not use Children 6 to under 12 years of age 10 mL (25 mg) Adults and children 12 years of age and over 10 mL (25 mg) to 20 mL (50 mg)

Warnings & Precautions
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 the child has • a breathing problem such as chronic bronchitis • glaucoma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product • marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Purpose

Purpose Antihistamine

Do Not Use

Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin

When Using

When using this product • marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children

Keep Out of Reach of Children

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

Questions

Questions or comments? (855) 879-4368


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