Complete Allergy Medicine

Manufacturer: Chain Drug Consortium, LLC
Effective date: 2018-12-06
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-02 00:44:13

Label at a glance#

ProductComplete Allergy Medicine

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

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

Dosage and administration

take every 4 to 6 hours do not take more than 6 times in 24 hours adults and children 12 years of age and over take 1 to 2 capsules children 6 to under 12 years of age take 1 capsule children under 6 years of age do not use

Contacts and useful links#

PhoneLabel contact1-877-753-3935

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

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 or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

take every 4 to 6 hours
do not take more than 6 times in 24 hours

adults and children 12 years of age and over	take 1 to 2 capsules
children 6 to under 12 years of age	take 1 capsule
children under 6 years of age	do not use

Other information

OTHER SAFETY INFORMATION

read the directions, warnings and accompanying label information before use
store at room temperature 15º to 30ºC (59º to 86ºF)
protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose, starch

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL®

Complete Allergy Medicine

ALLERGY RELIEF

Antihistamine/Diphenhydramine HCl 25 mg

Relieves: •Sneezing •Itchy, Watery Eyes

•Runny Nose •Itchy Throat

Capsules

Each capsule individually banded for your protection

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl®.

DISTRIBUTED BY:

CHAIN DRUG CONSORTIUM, LLC

3301 NW BOCA RATON BLVD., SUITE 101

BOCA RATON, FL 33431

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier Value Complete Allergy Medicine Capsule

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68016-277-06	EA - Each	68016-277	57bf5dce-fc87-413a-9539-1221870d11f2	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	4
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	4
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	4
LACTOSE, UNSPECIFIED FORM	INACTIVE INGREDIENT	J2B2A4N98G	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Complete Allergy Medicine
Diphenhydramine HCl
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
LACTOSE, UNSPECIFIED FORM
STARCH, CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68016-277	68016-277-06, 68016-277-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
D&C RED NO. 28	767IP0Y5NH	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN	2G86QN327L	IACT
LACTOSE, UNSPECIFIED FORM	J2B2A4N98G	IACT
STARCH, CORN	O8232NY3SJ	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 178 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GELATIN	GELATIN	2G86QN327L	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	TABLET / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, FILM COATED / ORAL	0.16 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, CHEWABLE / ORAL		24 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	MOUTHWASH / BUCCAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION / INTRAMUSCULAR	16 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	INSERT / VAGINAL		147 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SOLUTION / ORAL	0.04 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	SOAP / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
LACTOSE, UNSPECIFIED FORM	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE, UNSPECIFIED FORM	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE, UNSPECIFIED FORM	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, LIQUID FILLED / ORAL		1042 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
LACTOSE, UNSPECIFIED FORM	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	GUM, CHEWING / BUCCAL		102 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	WAFER / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
LACTOSE, UNSPECIFIED FORM	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, COATED / ORAL		288 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, DELAYED RELEASE / ORAL		713 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
LACTOSE, UNSPECIFIED FORM	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE, UNSPECIFIED FORM	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	ELIXIR / ORAL	12.5 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, EXTENDED RELEASE / ORAL		239 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
LACTOSE, UNSPECIFIED FORM	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE, UNSPECIFIED FORM	LACTOSE	J2B2A4N98G	POWDER / RESPIRATORY (INHALATION)	90 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / SUBLINGUAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	POWDER / ORAL	100 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
LACTOSE, UNSPECIFIED FORM	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SHAMPOO / TOPICAL		2 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
LACTOSE, UNSPECIFIED FORM	LACTOSE	J2B2A4N98G	TABLET / SUBLINGUAL		352 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE, UNSPECIFIED FORM	LACTOSE	J2B2A4N98G	TABLET, DELAYED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION / INTRAVENOUS	20 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL		13 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / SUBLINGUAL		409 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE, UNSPECIFIED FORM	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM / SUBLINGUAL	0.07 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL		7 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	ELIXIR / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / ORAL	1.13 mg/15ml		Exact identifier — unii candidate 37 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii candidate 22 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
6461df1e-4bac-4213-81d3-dcf85a0e5748			59afc080-4e52-497e-aaac-2d8f636b86b7	2018-12-06	Warnings	Exact identifier spl id: 6461df1e-4bac-4213-81d3-dcf85a0e5748 spl set id: 59afc080-4e52-497e-aaac-2d8f636b86b7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.