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NDC 76281-0319-26 Maximum Strength Adult Allergy Relief 50 mg/20mL Details

Maximum Strength Adult Allergy Relief 50 mg/20mL

Maximum Strength Adult Allergy Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by AptaPharma Inc.. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 76281-0319-26
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	76281-0319
Product ID	76281-319_5d22e778-08f5-4aad-8596-299a1c910b13
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Maximum Strength Adult Allergy Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	DIPHENHYDRAMINE HCl
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/20mL
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	AptaPharma Inc.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2022-12-31

Package

Package Images

NDC 76281-0319-26 (76281031926)

Pricing Information	N/A
NDC Package Code	76281-319-26
Billing NDC	76281031926
Package	237 mL in 1 BOTTLE (76281-319-26)
Marketing Start Date	2018-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 481a83d4-a927-4148-82cc-70e06f058ddb Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient (in each 20 mL)

Diphenhydramine HCl 50 mg

SPL UNCLASSIFIED SECTION

Purpose

Diphenhydramine HCl ............................. Antihistamine

SPL UNCLASSIFIED SECTION

Uses

■ temporarily relieves these symptoms due to hay fever or

other respiratory allergies: • sneezing • itching of the nose or throat

• runny nose • itchy watery eyes ■ temporarily relieves these

symptoms due to the common cold: • sneezing • runny nose

SPL UNCLASSIFIED SECTION

Warnings

Do not use

• with any other product containing diphenhydramine, even one

used on skin

• to make a child sleepy

SPL UNCLASSIFIED SECTION

Ask a doctor before use if you have

• a breathing problem such as chronic bronchitis

• glaucoma

• trouble urinating due to enlarged prostate gland

SPL UNCLASSIFIED SECTION

Ask a doctor or pharmacist before use if you are taking

sedatives or tranquilizers

SPL UNCLASSIFIED SECTION

When using this product

• marked drowsiness may occur

• avoid alcoholic drinks

• sedatives and tranquilizers may increase drowsiness

• be careful when driving a motor vehicle or operating machinery

• excitability may occur, especially in children

SPL UNCLASSIFIED SECTION

If pregnant or breast feeding, ask a health professional before use

SPL UNCLASSIFIED SECTION

Keep out of reach of children. In case of overdose, get

medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Directions

• if needed, take every 4-6 hours, or as directed by a

doctor

• do not take more than 6 doses in 24 hours

• not to exceed 300 mg in 24 hours

• mL=milliliter

Age Dose
adults and children 12 years and older	10 mL to 20 mL
children under 12 years of age	Consult a doctor

SPL UNCLASSIFIED SECTION

Other information

• each 20 mL contains: sodium 12 mg

• store at 20-25°C (68-77°F).

• dosage cup provided

SPL UNCLASSIFIED SECTION

Inactive ingredients

Anhydrous citric acid, flavor, purified water, sodium benzoate, sucrose

SPL UNCLASSIFIED SECTION

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Principal Display Panel

CVS

HealthTM

Compare to the

active ingredient in

Benadryl® Allergy*

MAXIMUM STRENGTH

Adult

ALLERGY RELIEF

LIQUID MEDICATION

Free of alcohol, dyes &

artificial sweeteners

DIPHENHYDRAMINE HCl

ORAL SOLUTION

Antihistamine

Relieves:

• Sneezing; Runny nose

• Itchy, watery eyes

• Itchy throat

Cherry Flavor

For Ages

12 and Over

8 FL OZ (237 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences

*This product is not manufactured or distributed by McNeil

Consumer Healthcare, distributor of Benadryl® Allergy.

Lot:

Exp:

LR-118 #344121

0 50428 60619 3

DRUG FACTS →

CONTINUED

ON BACK

PEEL

HERE

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2018 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-34801

√CVS®Quality

Money Back Guarantee

Maximum Strength Adult Allergy Relief by CVS Pharmacy, Inc.

res

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH ADULT ALLERGY RELIEF

diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76281-319
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76281-319-26	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	11/01/2018

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Name	Address	ID/FEI	Business Operations
Establishment
AptaPharma Inc.		790523323	manufacture(76281-319)

Revised: 1/2019

Document Id: 5d22e778-08f5-4aad-8596-299a1c910b13

Set id: 481a83d4-a927-4148-82cc-70e06f058ddb

Version: 1

Effective Time: 20190107

Search by Drug Name or NDC

NDC 76281-0319-26 Maximum Strength Adult Allergy Relief 50 mg/20mL Details

Maximum Strength Adult Allergy Relief 50 mg/20mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 76281-0319-26 (76281031926)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 481a83d4-a927-4148-82cc-70e06f058ddb Details

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Principal Display Panel

INGREDIENTS AND APPEARANCE

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