ALLERGY RELIEF- diphenhydramine hcl tablet

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

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
P & L Development, 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  sneezing  itchy, watery eyes itching of the nose or throat - runny nose  - sneezing  - itchy, watery eyes - 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:
59726-866-12, 59726-866-40

ALLERGY RELIEF- diphenhydramine hcl tablet

P & L Development, 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.

----------

DRUG FACTS

Active ingredient (in each tablet)

Diphenhydramine HCL 25 mg

Purpos e

Antihistamine

Us es

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose

sneezing

itchy, watery eyes

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

glaucoma

trouble urinating due to an enlarged 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 drinks

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

excitability may occur, especially in children

If pregnant of 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 doses in 24 hours

adults and children 12 years and

over

take 1 to 2 tablets

children 6 to under 12 years

take 1 tablet

children under 6 years

do not use

Other information

each tablet contains: calcium 25 mg

store between 20-25ºC (68-77ºF)

protect from light and moisture

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake,

dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose,

polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

Compare to the active ingredient in Benadryl® Allergy Ultratab® Tablets†

allergy relief

diphenhydramine HCL 25 mg

antihistamine

for allergy relief:

runny nose

sneezing

itchy, watery eyes

itchy nose or throat

tablets

†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor

of Benadryl® Allergy Ultratab® Tablets.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: PL Developments

200 Hicks Street, Westbury, NY 11590

Product Label

READYinCASE Allerg y Relief

ALLERGY RELIEF

diphenhydramine hcl tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 726 -8 6 6

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

CARNAUBA WAX (UNII: R12CBM0 EIZ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

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

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

P & L Development, LLC

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

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

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

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

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

PINK

S core

no sco re

S hap e

CAPSULE

S iz e

11mm

Flavor

Imprint Code

T;0 6 1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:59 726 -8 6 6 -

12 in 1 CARTON

0 7/31/20 19

1

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

2

NDC:59 726 -8 6 6 -

40 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/31/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt336

0 7/31/20 19

Labeler -

P & L Development, LLC (800014821)

Revised: 9/2019

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