SPL v2
SPL
SPL Set ID 20e164b8-4cbc-cf3f-e063-6394a90a9d0c
Route
ORAL
Published
Effective Date 2024-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium D&c Red No. 27 Anhydrous Dibasic Calcium Phosphate Magnesium Stearate Microcrystalline Cellulose Polyvinyl Alcohol, Unspecified Titanium Dioxide Talc

Identifiers & Packaging

Pill Appearance
Imprint: D25 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-08-01 Until 2027-12-31

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
    • itchy nose or throat
  • temporarily relieves these symptoms of the common cold:
    • runny nose
    • sneezing 
Section 42229-5

Distributed by:

Advanced Rx LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

MADE IN THE USA

Section 51945-4

NDC 80513-722-06

Compare to Benadryl ®Allergy Ultratab ®active ingredient*

ALLERGY RELIEF

DIPHENHYDRAMINE HCl 25 mg

ANTIHISTAMINE

RELIEVES:

Sneezing

Itchy, Watery Eyes

Runny Nose



Itchy Throat

600

MINI TABLETS

*This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Benadryl ®Allergy Ultratab ®

Section 53414-9

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

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 or 2 caplets

Children 6 to under 12 years of age:1 caplet

Children under 6 years of age: do not use

Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Other Information
  • Each caplet contains:Calcium 23.52 mg
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • read all product information before using.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Inactive Ingredients

Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Red #27, Dicalcium Phosphate, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyvinyl alcohol, Titanium dioxide, Talc

Questions Or Comments?

Call toll free 1-800-630-8895

Monday through Friday 9 AM - 5 PM EST.

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
Ask Your 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
    • sneezing
    • itchy, watery eyes
    • itchy nose or throat
  • temporarily relieves these symptoms of the common cold:
    • runny nose
    • sneezing 
Section 42229-5 (42229-5)

Distributed by:

Advanced Rx LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

MADE IN THE USA

Section 51945-4 (51945-4)

NDC 80513-722-06

Compare to Benadryl ®Allergy Ultratab ®active ingredient*

ALLERGY RELIEF

DIPHENHYDRAMINE HCl 25 mg

ANTIHISTAMINE

RELIEVES:

Sneezing

Itchy, Watery Eyes

Runny Nose



Itchy Throat

600

MINI TABLETS

*This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Benadryl ®Allergy Ultratab ®

Section 53414-9 (53414-9)

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

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 or 2 caplets

Children 6 to under 12 years of age:1 caplet

Children under 6 years of age: do not use

Do Not Use (do not use)
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Other Information (Other information)
  • Each caplet contains:Calcium 23.52 mg
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • read all product information before using.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Inactive Ingredients (Inactive ingredients)

Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Red #27, Dicalcium Phosphate, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyvinyl alcohol, Titanium dioxide, Talc

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-630-8895

Monday through Friday 9 AM - 5 PM EST.

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
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.

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (ask a doctor before use if you have)
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
Ask Your Doctor Or Pharmacist Before Use If You Are (ask your doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers.

Advanced Ingredient Data


Raw Label Data

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