Allergy Relief Diphenhydramine Hcl, 25 Mg Antihistamine

Allergy Relief Diphenhydramine Hcl, 25 Mg Antihistamine
SPL v4
SPL
SPL Set ID edc244d6-eb0b-d3c9-e053-2a95a90a2622
Route
ORAL
Published
Effective Date 2022-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Silicon Dioxide Carnauba Wax Microcrystalline Cellulose D&c Red No. 27 Anhydrous Dibasic Calcium Phosphate Titanium Dioxide Lactose, Unspecified Form Croscarmellose Sodium Hypromellose, Unspecified Polyethylene Glycol, Unspecified Polysorbate 80 Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: 048;D Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2016-07-11 Until 2027-06-24

Description

Diphenhydramine HCl 25 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

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
Section 42229-5

* This product is not manufactured or distributed by

JOHNSON & JOHNSON CONSUMER INC,

McNeil Consumer Healthcare Division,

distributor of Benadryl® Allergy ULTRATABS®

Distributed by:

Lil’ Drug Store Products, Inc.

Cedar Rapids, IA 52404

Section 51945-4

COMPARE TO THE ACTIVE INGREDIENTS IN

Benadryl® Allergy ULTRATABS®

Allergy Relief

Diphenhydramine HCl 25 mg,

Antihistamine

Relieves Symptoms of

Hay Fever, Common Cold and [tablet image here]

Other Upper Respiratory Allergies actual size

2 TABLETS IN EACH PACKET

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

take 1 to 2 tablets
children 6 to under 12 years take 1 tablet
children under 6 years do not use
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Active Ingredient

Diphenhydramine HCl 25 mg

Other Information
  • each tablet may contain: calcium 25 mg
  • store at room temperature 68°-77°F (20°-25°C)
  • protect from light and moisture
Inactive Ingredients

carnauba wax

may contain
, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate
, hypromellose, lactose
, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80
, titanium dioxide

Questions Or Comments

call toll-free 800-351-2000 (M-F 8:00 AM-4:30 PM CST)

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 tranquilizers or sedatives.

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

Structured Label Content

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
Section 42229-5 (42229-5)

* This product is not manufactured or distributed by

JOHNSON & JOHNSON CONSUMER INC,

McNeil Consumer Healthcare Division,

distributor of Benadryl® Allergy ULTRATABS®

Distributed by:

Lil’ Drug Store Products, Inc.

Cedar Rapids, IA 52404

Section 51945-4 (51945-4)

COMPARE TO THE ACTIVE INGREDIENTS IN

Benadryl® Allergy ULTRATABS®

Allergy Relief

Diphenhydramine HCl 25 mg,

Antihistamine

Relieves Symptoms of

Hay Fever, Common Cold and [tablet image here]

Other Upper Respiratory Allergies actual size

2 TABLETS IN EACH PACKET

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

take 1 to 2 tablets
children 6 to under 12 years take 1 tablet
children under 6 years do not use
Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Active Ingredient

Diphenhydramine HCl 25 mg

Other Information
  • each tablet may contain: calcium 25 mg
  • store at room temperature 68°-77°F (20°-25°C)
  • protect from light and moisture
Inactive Ingredients

carnauba wax

may contain
, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate
, hypromellose, lactose
, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80
, titanium dioxide

Questions Or Comments (Questions or Comments)

call toll-free 800-351-2000 (M-F 8:00 AM-4:30 PM CST)

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 tranquilizers or sedatives.

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

Advanced Ingredient Data


Raw Label Data

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