OTC Medication Information: Allergy Relief

ALLERGY RELIEF- diphenhydramine hydrochloride tablet, film coated
Wal-Mart Stores Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

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

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.

Directions

  • 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

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

Questions or comments?

1-888-287-1915

Principal display panel

equate™

NDC 49035-164-12

Compare to Benadryl® Allergy Ultratabs® Active Ingredient*

Dye Free
Allergy Relief
Diphenhydramine HCI, 25 mg
Antihistamine

Easy to Swallow
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 call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

PRODUCT OF INDIA, AND JAPAN

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy Ultratabs®.
50844 REV0419A61412

Equate 44-614
(click image for full-size original)

Equate 44-614

ALLERGY RELIEF
diphenhydramine hci tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-164
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
SILICON DIOXIDE
STEARIC ACID
TALC
Product Characteristics
Color white Score no score
Shape OVAL Size 11mm
Flavor Imprint Code 44;614
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49035-164-12 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (49035-164-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 08/15/2018
Labeler — Wal-Mart Stores Inc (051957769)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (49035-164)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 pack (49035-164)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 manufacture (49035-164), pack (49035-164)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (49035-164)

Revised: 06/2022 Wal-Mart Stores Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.