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

• sneezing
• nasal congestion
• runny nose
• itchy, watery eyes.

Temporarily relieves these symptoms due to 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

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

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, or as directed by a doctor
• 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: ask a doctor.

Other information

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

Inactive ingredients

Colloidal silicon dioxide, corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc and titanium dioxide.

Questions or comments?

Please call 1-800-525-5097

Monday - Friday 9am-5pm MST.

Package Labeling:

HANDY SOLUTIONS ALLERGY RELIEF 
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-213(NDC: 67751-099)
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
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	PH25
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-213-01	2 in 1 POUCH; Type 0: Not a Combination Product	07/14/2021
2	NDC: 67751-213-02	1 in 1 CARTON	07/14/2021
2		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/14/2021	03/01/2023

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	repack(67751-213) , relabel(67751-213)

Revised: 3/2023

Document Id: f70ce1a6-c335-025e-e053-6294a90ae53f

34390-5

Set id: c71768cd-51fe-cb88-e053-2995a90a682a

Version: 5

Effective Time: 20230316