Active Ingredient (In Each Banded Capsule)
Diphenhydramine HCl 25 mg
Complete Allergy Medicine Capsule
FDA Label NDC 57243-190
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Salado Sales, Inc. for the product Complete Allergy Medicine (NDC 57243-190). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each banded capsule), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant of breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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: PRODUCT SEALED IN PLASTIC STRIPS, CAPSULE BANDED FOR YOUR PROTECTION. 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: PRODUCT SEALED
IN PLASTIC STRIPS, CAPSULE
BANDED FOR YOUR PROTECTION. DO
NOT USE 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 REV1016S19008
Distributed by Consumer Value Products, Inc.
P.O. Box 6115, Temple, Texas 76502
CVPproducts.com
Cvp 44-190 (Cvp 44 190 1)
* Please review the disclaimer below.
