Complete Allergy Medicine: Package Insert and Label Information

COMPLETE ALLERGY MEDICINE- diphenhydramine hydrochloride 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.

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 12
years and over
1 to 2 capsules
children 6 to under 12
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 44-190
(click image for full-size original)

CVP 44-190

COMPLETE ALLERGY MEDICINE
diphenhydramine hcl capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57243-190
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
BUTYLPARABEN
D&C RED NO. 28
FD&C BLUE NO. 1
GELATIN
MAGNESIUM STEARATE
METHYLPARABEN
PROPYLPARABEN
POLYSORBATE 80
STARCH, CORN
FD&C RED NO. 40
ANHYDROUS LACTOSE
SILICON DIOXIDE
Product Characteristics
Color PINK, WHITE Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 44;107
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57243-190-08 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 12 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (57243-190-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 03/15/1990
Labeler — Salado Sales, Inc. (009830555)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 PACK (57243-190)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 MANUFACTURE (57243-190), PACK (57243-190)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 PACK (57243-190)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 PACK (57243-190)

Revised: 05/2020 Salado Sales, Inc.

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