COMPLETE ALLERGY MEDICINE- diphenhydramine hcl capsule

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

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
Salado Sales, 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:
57243-190-08

COMPLETE ALLERGY MEDICINE- diphenhydramine hcl capsule

Salado Sales, 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.

----------

CVP 44-190

Active ingredient (in each banded capsule)

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

glaucoma

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

alcohol, sedatives, and tranquilizers may increase drowsiness

avoid alcoholic beverages

use caution when driving a motor vehicle or operating machinery

marked drowsiness may occur

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

do not take more than 6 doses in 24 hours

adults and children

years and over

1 to 2

capsules

children 6 to under

years

1 capsule

children under 6

years

do not use

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS

TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

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

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose

anhydrous, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

COMPARE TO

BENADRYL®

ACTIVE INGREDIENT*

CVP

Health

COMPLETE

ALLERGY

MEDICINE

DIPHENHYDRAMINE HCl, 25 mg

ANTIHISTAMINE

®

RELIEVES:

SNEEZING RUNNY NOSE ITCHY, WATERY EYES

DUE TO HAY FEVER OR THE COMMON COLD

24 CAPSULES

EACH CAPSULE INDIVIDUALLY

BANDED FOR YOUR PROTECTION

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

TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the

registered trademark Benadryl®.

50844 REV1117S19008

Distributed by Consumer Value Products, Inc.

P.O. Box 6115, Temple, Texas 76502

CVPproducts.com

CVP 4 4 -190

COMPLETE ALLERGY MEDICINE

diphenhydramine hcl capsule

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:57243-19 0

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

BUTYLPARABEN (UNII: 3QPI1U3FV8 )

D&C RED NO . 2 8 (UNII: 76 7IP0 Y5NH)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

GELATIN (UNII: 2G8 6 QN327L)

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

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

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

STARCH, CO RN (UNII: O8 232NY3SJ)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

Product Characteristics

Color

PINK, WHITE

S core

no sco re

S hap e

CAPSULE

S iz e

14mm

Flavor

Imprint Code

44;10 7

Contains

Packag ing

Salado Sales, Inc.

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:57243-19 0 -0 8

2 in 1 CARTON

0 3/15/19 9 0

1

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

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 3/15/19 9 0

Labeler -

Salado Sales, Inc. (009830555)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(57243-19 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

MANUFACTURE(57243-19 0 ) , PACK(57243-19 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(57243-19 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(57243-19 0 )

Revised: 5/2020

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