perrigo allergy relief drug facts

perrigo allergy relief drug facts
SPL v9
SPL
SPL Set ID 2cfa69b4-e33f-442a-a6df-b021b041da14
Route
oral
Published
Effective Date 2023-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
carnauba wax crospovidone (15 mpa.s at 5%) d&c red no. 27 aluminum lake dibasic calcium phosphate dihydrate hypromellose, unspecified magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polysorbate 80 stearic acid titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L479;25 Shape: oval Color: pink Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 1991-08-20 Until 2021-06-04

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg


Medication Information

Active Ingredient

Diphenhydramine HCl 25 mg

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
Purpose

Antihistamine

Directions
  • 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 over

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.
  • do not use if blister unit is broken or torn
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

Description

Diphenhydramine HCl 25 mg

Principal Display Panel

GOODSENSE®

Easy to Swallow

Allergy Relief Tablets

Diphenhydramine HCl 25 mg – Antihistamine

Actual Size

Small Tablet Size

  • Sneezing
  • Itchy, Watery Eyes
  • Runny Nose
  • Itchy Throat

Compare to active ingredient of Benadryl® Allergy Ultratab®

24 Tablets

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

1-800-719-9260

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

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

Active Ingredient (Active ingredient (in each tablet))

Diphenhydramine HCl 25 mg

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
Purpose

Antihistamine

Directions
  • 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 over

1 to 2 tablets

children 6 to under 12 years

1 tablet

children under 6 years

do not use

Other Information (Other information)
  • each tablet contains: calcium 20 mg
  • store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • do not use if blister unit is broken or torn
Inactive Ingredients (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

Principal Display Panel

GOODSENSE®

Easy to Swallow

Allergy Relief Tablets

Diphenhydramine HCl 25 mg – Antihistamine

Actual Size

Small Tablet Size

  • Sneezing
  • Itchy, Watery Eyes
  • Runny Nose
  • Itchy Throat

Compare to active ingredient of Benadryl® Allergy Ultratab®

24 Tablets

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

1-800-719-9260

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

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

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