Handy Solutions Allergy Relief

Handy Solutions Allergy Relief by

Drug Labeling and Warnings

Handy Solutions Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc., Ultra Seal Corporation, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HANDY SOLUTIONS ALLERGY RELIEF- diphenhydramine hydrochloride tablet 
Navajo Manufacturing Company 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.

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Handy Solutions Allergy Relief

Drug Facts

Active ingredient (in each caplet)

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 itchy 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

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

Ask a doctor or pharmacist before use if

you are taking sedatives or tranquilizers

When using this product

drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children
be careful when driving a motor vehicle or operating machinery

If pregnant or 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 right away.

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours
Adults and children 12 years of age and over: 1 to 2 caplets
Children 6 to under 12 years of age: 1 caplet
Children under 6 years of age: do not use this product in children under 6 years of age

Other information

Tamper evident. Do not use if packet is torn, cut or opened
Each caplet contains: Calcium 25 mg
Protect from light
Store at 25°C (77°F). Excursions permitted between 15°-30°C (59°-86°F)
Use by expiration date on package

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide

Questions or comments?

call 1-800-525-5097

Package Labeling:

HANDY SOLUTIONS ALLERGY RELIEF 
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-176
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	T061
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-176-01	1 in 1 CARTON	10/22/2016
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 67751-176-02	1 in 1 CARTON	10/22/2016
2		6 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 67751-176-04	2 in 1 POUCH; Type 0: Not a Combination Product	10/22/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/22/2016	11/04/2019

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	pack(67751-176)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-176) , repack(67751-176)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(67751-176)

Revised: 11/2019

Document Id: 972d0d44-b671-f93c-e053-2a95a90aece3

34390-5

Set id: ee4431a6-eda8-42ca-af43-523817e0091b

Version: 5

Effective Time: 20191112

 

Navajo Manufacturing Company Inc.