Sound Body 44-329-delisted

Sound Body 44-329-delisted
SPL v17
SPL
SPL Set ID 16a6a0d0-4585-419d-97d3-205a6761abe6
Route
ORAL
Published
Effective Date 2024-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Starch, Corn D&c Red No. 27 Aluminum Lake Dibasic Calcium Phosphate Dihydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;329 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 1990-03-02 Until 2025-10-16

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:
    • itchy, watery eyes
    • sneezing
    • runny nose
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • sneezing
    • runny nose
Directions
  • do not take more than directed
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times 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
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • each tablet contains: calcium 30 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number
Inactive Ingredients

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

SOUNDBODY

*Compare to the active

ingredient in Benadryl®

Allergy ULTRATAB® Tablets

NDC 50844-932-12

Allergy Relief

Diphenhydramine HCl 25 mg,
Antihistamine

RELIEVES: Sneezing, Runny Nose,

Itchy Throat & Itchy, Watery Eyes

100 TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed

by Johnson & Johnson Corporation, owner of the

registered trademark Benadryl® Allergy ULTRATAB®

Tablets.        50844        REV0721D32912

Manufactured for Big Lots Stores, Inc.

by LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788 USA

V#733000      ITEM#022732912

Sound Body 44-329
When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution 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.

Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
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:
    • itchy, watery eyes
    • sneezing
    • runny nose
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • sneezing
    • runny nose
Purpose

Antihistamine

Directions
  • do not take more than directed
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times 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
Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)
  • each tablet contains: calcium 30 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

SOUNDBODY

*Compare to the active

ingredient in Benadryl®

Allergy ULTRATAB® Tablets

NDC 50844-932-12

Allergy Relief

Diphenhydramine HCl 25 mg,
Antihistamine

RELIEVES: Sneezing, Runny Nose,

Itchy Throat & Itchy, Watery Eyes

100 TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed

by Johnson & Johnson Corporation, owner of the

registered trademark Benadryl® Allergy ULTRATAB®

Tablets.        50844        REV0721D32912

Manufactured for Big Lots Stores, Inc.

by LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788 USA

V#733000      ITEM#022732912

Sound Body 44-329
When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution 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.

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)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the 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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