Adult Allergy Relief (usp)

Adult Allergy Relief (usp)
SPL v2
SPL
SPL Set ID 08288825-0f38-b6a3-e063-6394a90aa358
Route
ORAL
Published
Effective Date 2024-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Propylene Glycol Sucrose Corn Syrup Neotame Sodium Chloride Sucralose Starch, Corn Maltitol Glyceryl Mono And Dipalmitostearate Hydroxypropyl Betadex Acacia Water Fd&c Red No. 40 Polyethylene Glycol 400 Povidone K30 Carrageenan Trisodium Citrate Dihydrate

Identifiers & Packaging

Pill Appearance
Shape: rectangle Color: red Size: 15 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-20
Description

Active Ingredient and Purpose

Purpose

Active Ingredient and Purpose

Medication Information

Purpose

Active Ingredient and Purpose

Description

Active Ingredient and Purpose

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

■ runny nose

■ itchy, watery eyes

■ sneezing

■ itching of the nose or throat

• temporarily relieves these symptoms due to the common cold:

■ runny nose

■ sneezing

Section 55105-1
Active ingredient Purpose
Diphenhydramine HCl 25 mg................. Anthistamine

Directions
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
  • chew each piece thoroughly before swallowing

Age (Yrs) Dose ( per piece)
adults and children 12 years and over 1 to 2 pieces (25mg to 50 mg)
children under 12 years do not use

Do Not Use



• To make child sleepy

• with any other product containing diphenhydramine, even one used on skin

Other Information

• each piece: contains sodium 9 mg.

low sodium

• store in a cool dry place between 20-25°C (68-77°F).

• Child Resistant Container; do not use if printed seal under cap is broken or missing.

Inactive Ingredients

FD&C Red# 40, flavors, geleol mono and diglycerides, glucose syrup, gum atabic,

hydroxypropyl betadex, maltitol solution, neotame, polyethylene glycol 400, povidone K30, propylene

glycol, purified water, seaweed extract ( carrageenan), sodium chloride, starch, sucralose, sucrose,

trisodium citrate dihydrate.

Questions Or Comments?

Call 941-203-4590 or visit calmco.com

Principal Display Panel

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

Active Ingredient and Purpose

Active Ingredient and Purpose

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 (1-800-222-1222) right away.

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

■ runny nose

■ itchy, watery eyes

■ sneezing

■ itching of the nose or throat

• temporarily relieves these symptoms due to the common cold:

■ runny nose

■ sneezing

Section 55105-1 (55105-1)
Active ingredient Purpose
Diphenhydramine HCl 25 mg................. Anthistamine

Directions
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
  • chew each piece thoroughly before swallowing

Age (Yrs) Dose ( per piece)
adults and children 12 years and over 1 to 2 pieces (25mg to 50 mg)
children under 12 years do not use

Do Not Use (Do not use)



• To make child sleepy

• with any other product containing diphenhydramine, even one used on skin

Other Information

• each piece: contains sodium 9 mg.

low sodium

• store in a cool dry place between 20-25°C (68-77°F).

• Child Resistant Container; do not use if printed seal under cap is broken or missing.

Inactive Ingredients

FD&C Red# 40, flavors, geleol mono and diglycerides, glucose syrup, gum atabic,

hydroxypropyl betadex, maltitol solution, neotame, polyethylene glycol 400, povidone K30, propylene

glycol, purified water, seaweed extract ( carrageenan), sodium chloride, starch, sucralose, sucrose,

trisodium citrate dihydrate.

Questions Or Comments? (Questions or Comments?)

Call 941-203-4590 or visit calmco.com

Principal Display Panel

When Using This Product (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

Active Ingredient and Purpose

Active Ingredient and Purpose

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

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 (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:46.893034 · Updated: 2026-03-14T23:05:42.419463