Allergy

Allergy
SPL v2
SPL
SPL Set ID e5339c39-1d66-b283-e053-2995a90a4317
Route
ORAL
Published
Effective Date 2014-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Red No. 27 Magnesium Stearate Hypromellose, Unspecified Lactose, Unspecified Form Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Silicon Dioxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AZ048 Shape: capsule Color: pink Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-09-12

Description

Active ingredient (in each tablet) Diphenhydramine HCl 25 mg

Purpose

Anrihistamine


Medication Information

Purpose

Anrihistamine

Description

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
Section 50565-1

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).

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

​Warnings

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

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

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

croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Questions Or Comments?

call toll-free 1-877-507-6516 (M-F 8AM – 4:30PM CST)

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
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.

Allergy (lil' Drug Store) Pouch & Sleeve Label Pdp/package

[caduceus]

Compare to the active ingredient in

Benadryl ® Allergy ULTRATAB Tablets*

Allergy

Diphenhydramine HCl 25 mg

Antihistamine

Relieves

• Runny Nose • Sneezing

• Itchy, Watery Eyes

• Itchy Nose or Throat

*This product is not manufactured or distributed by

Kenvue, Inc. Lil' Drug Store Products does not own the

Benadryl Allergy ULTRATAB ® trademark.

50 PACKETS OF 2 CAPLETS

[UPC]

3 66715 97117 3


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 50565-1 (50565-1)

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).

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Anrihistamine

Warnings

​Warnings

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

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Other Information (Other information)
  • each tablet may contain: calcium 25mg
  • store at room temperature 68º-77ºF (20º-25ºC)
  • protect from light and moisture
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Questions Or Comments? (Questions or comments?)

call toll-free 1-877-507-6516 (M-F 8AM – 4:30PM CST)

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
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.

Allergy (lil' Drug Store) Pouch & Sleeve Label Pdp/package (Allergy (Lil' Drug Store) Pouch & Sleeve Label - PDP/Package)

[caduceus]

Compare to the active ingredient in

Benadryl ® Allergy ULTRATAB Tablets*

Allergy

Diphenhydramine HCl 25 mg

Antihistamine

Relieves

• Runny Nose • Sneezing

• Itchy, Watery Eyes

• Itchy Nose or Throat

*This product is not manufactured or distributed by

Kenvue, Inc. Lil' Drug Store Products does not own the

Benadryl Allergy ULTRATAB ® trademark.

50 PACKETS OF 2 CAPLETS

[UPC]

3 66715 97117 3


Advanced Ingredient Data


Raw Label Data

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