dye-free allergy relief

dye-free allergy relief
SPL v4
SPL
SPL Set ID 36c840d3-dfb2-44b6-b2a1-b87cb7c76be6
Route
oral
Published
Effective Date 2023-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
gelatin glycerin polyethylene glycol 400 povidone propylene glycol water sorbitol titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 611 Shape: capsule Color: white Size: 14 mm Score: 1
Marketing Status
otc monograph drug active Since 2023-05-01

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg


Medication Information

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

Antihistamine

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
  • swallow whole; do not crush, chew or dissolve
  • adults and children 12 years of age and over - take 1 to 2 softgels
  • children 6 to under 12 years of age              - take 1 softgel
  • children under 6 years of age                      - do not use

Other Information
  • store between 20-25ºC (68 to 77°F). Avoid high humidityandexcessive heat.
  • Protect from light, heat, humidity
Inactive Ingredients

gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol-sorbitan solution, titanium dioxide

Description

Diphenhydramine HCl 25 mg

Principal Display Panel

Section 42229-5

DIST. BY MEIJER

DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Questions Or Comments?

Call 1-888-287-1915

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
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)

If Pregnant or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Capsule)

Diphenhydramine HCl 25 mg

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

Antihistamine

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
  • swallow whole; do not crush, chew or dissolve
  • adults and children 12 years of age and over - take 1 to 2 softgels
  • children 6 to under 12 years of age              - take 1 softgel
  • children under 6 years of age                      - do not use

Other Information (Other information)
  • store between 20-25ºC (68 to 77°F). Avoid high humidityandexcessive heat.
  • Protect from light, heat, humidity
Inactive Ingredients (Inactive ingredients)

gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol-sorbitan solution, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Section 42229-5 (42229-5)

DIST. BY MEIJER

DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Questions Or Comments? (Questions or comments?)

Call 1-888-287-1915

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
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)

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

ask a health professional before use.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (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
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

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