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:

Label

HANDY SOLUTIONS ALLERGY RELIEF 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-176
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScoreno score
ShapeOVALSize11mm
FlavorImprint Code T061
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67751-176-011 in 1 CARTON10/22/2016
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:67751-176-021 in 1 CARTON10/22/2016
26 in 1 PACKET; Type 0: Not a Combination Product
3NDC:67751-176-042 in 1 POUCH; Type 0: Not a Combination Product10/22/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/22/201611/04/2019
Labeler - Navajo Manufacturing Company Inc. (091917799)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004pack(67751-176)
Establishment
NameAddressID/FEIBusiness Operations
Navajo Manufacturing Company Inc.136941411relabel(67751-176) , repack(67751-176)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(67751-176)

Revised: 11/2019
 
Navajo Manufacturing Company Inc.