ALLERGY RELIEF- diphenhydramine hci tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
Wal-Mart Stores Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine - 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 - runny nose - itchy, watery eyes - sneezing - itching of the nose or throat - temporarily relieves these symptoms due to the common cold: runny nose sneezing - runny nose - sneezing
Authorization status:
OTC monograph final
Authorization number:
49035-164-12

ALLERGY RELIEF- diphenhydramine hci 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.

----------

Equate 44-614

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 drinks

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

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 4 4 -614

ALLERGY RELIEF

diphenhydramine hci tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 0 35-16 4

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE -

UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

STARCH, CO RN (UNII: O8 232NY3SJ)

DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TSZ9 7GEP)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

OVAL

S iz e

11mm

Flavor

Imprint Code

44;6 14

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:49 0 35-16 4-

1 in 1 CARTON

0 8 /15/20 18

1

10 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

0 8 /15/20 18

Labeler -

Wal-Mart Stores Inc (051957769)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

MANUFACTURE(49 0 35-16 4) , PACK(49 0 35-16 4)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(49 0 35-16 4)

Wal-Mart Stores Inc

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(49 0 35-16 4)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(49 0 35-16 4)

Revised: 6/2020

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