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FDA Approval

Allergy Relief

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Wal-Mart Stores Inc
DUNS: 051957769
Effective Date
May 28, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Diphenhydramine(25 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

LNK International, Inc.

Wal-Mart Stores Inc

967626305

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Allergy Relief

Product Details

NDC Product Code
49035-164
Application Number
M012
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
ORAL
Effective Date
May 28, 2025
Code: TC2D6JAD40Class: ACTIBQuantity: 25 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal display panel

equate™

NDC 49035-164-12

Compare to Benadryl® Allergy Ultratabs® Active Ingredient*

Dye Free
Allergy Relief
Diphenhydramine HCI, 25 mg
Antihistamine

Allergy relief for:
• Sneezing • Itchy, watery eyes
• Runny nose • Itchy throat

25
mg
EACH

100
TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING

Satisfaction guaranteed – For questions
or comments please call1-888-287-1915.

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

PRODUCT OF CHINA

*This product is not manufactured or
distributed by Johnson & Johnson
Corporation, owner of the registered
trademark Benadryl® Allergy Ultratabs®.
50844 REV0422B61412

Equate 44-614

Equate 44-614


INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

DOSAGE & ADMINISTRATION SECTION

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


WARNINGS SECTION

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

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.


STORAGE AND HANDLING SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

OTC - QUESTIONS SECTION

Questions or comments?

1-888-287-1915


INACTIVE INGREDIENT SECTION

Inactive ingredients

corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc


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