ALLERGY RELIEF- diphenhydramine hcl 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:
DOLGENCORP, LLC
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 itching of the nose or throat sneezing temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: - runny nose runny nose - itchy, watery eyes itchy, watery eyes - itching of the nose or throat itching of the nose or throat - sneezing sneezing - temporarily relieves these symptoms due to the common cold: runny nose sneezing temporarily relieves these symptoms due to the common cold: - runny nose runny nose - sneezing sneezing
Authorization status:
OTC monograph final
Authorization number:
55910-329-08, 55910-329-51

ALLERGY RELIEF- diphenhydramine hcl tablet, film coated

DOLGENCORP, LLC

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.

----------

Rexall 44-329

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

itching of the nose or throat

sneezing

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

glaucoma

a breathing problem such as emphysema or chronic bronchitis

difficulty in urination due to enlargement of the prostate gland

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 (1-800-222-1222) 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 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

use by expiration date on package

protect from moisture

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline

cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Principal Display Panel

Since 1903

Rexall®

Allergy Relief

Diphenhydramine HCl 25 mg

Antihistamine

Relief of

Sneezing

Runny nose

Itchy, watery eyes

Itchy throat

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

BROKEN OR MISSING

50844 REV1016B32951

Visit us at: Rexall.com or call 1-866-4-REXALL

MANUFACTURED FOR DOLGENCORP, LLC

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072 USA

Rexall 4 4 -329

ALLERGY RELIEF

diphenhydramine hcl tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:559 10 -329

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

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

D&C RED NO . 2 7 (UNII: 2LRS18 5U6 K)

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

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

STARCH, CO RN (UNII: O8 232NY3SJ)

TALC (UNII: 7SEV7J4R1U)

ANHYDRO US DIBASIC CALCIUM PHO SPHATE (UNII: L11K75P9 2J)

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

Product Characteristics

Color

PINK

S core

no sco re

S hap e

OVAL

S iz e

11mm

Flavor

Imprint Code

44;329

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:559 10 -329 -

1 in 1 CARTON

0 3/0 2/19 9 0

0 2/15/20 21

1

24 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:559 10 -329 -

36 5 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 3/0 2/19 9 0

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 3/0 2/19 9 0

Labeler -

DOLGENCORP, LLC (068331990)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(559 10 -329 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(559 10 -329 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

MANUFACTURE(559 10 -329 ) , PACK(559 10 -329 )

DOLGENCORP, LLC

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(559 10 -329 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(559 10 -329 )

Revised: 4/2020

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