ALLERGY- diphenhydramine hydrochloride tablet 
Strategic Sourcing Services LLC

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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Health Mart Allergy Tablets

Active Ingredients (in each tablet)

Diphenhydramine HCl 25mg

Purpose

Antihistimine

Uses

Temporarily relieves symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

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

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • 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,

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. (1-800-222-1222)

 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 tablets
children 6 to under 12 years of age    1 tablet
children under 6 years of age        do not use this product in children under 6
children under 4 years of age        do not use

each tablet contains: calcium 25 mg/tablet

store at room temperature 15°-30°C (59°-86°F)

protect from light and moisture

do not use if imprinted safety seal under cap is broken or missing

*This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl Allergy ULTRATAB

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, DandC Red No. 27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, and titanium dioxide. *contains one or more of these ingredients

Questions or Comments

Call toll free 1-877-753-3935 Monday through Friday 9AM – 5PM EST

Distributed by:
PL Developments
Westbury, NY 11590, USA

Package Label

NDC 59726-690-01

*Compare to the active ingredient in
Benadryl® Allergy ULTRATAB®

Antihistimine Allergy Tablets
Diphenhydramine Hydrochloride 25mg

For Allergy Relief
Sneezing, Itchy, Watery Eyes
Runny Nose, Itchy Throat

100 tablets

Product Bottle Label


Diphenhydramine Hydrochloride
ALLERGY 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0058
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINK (PINK) Scoreno score
ShapeOVAL (Oblong) Size11mm
FlavorImprint Code V25;EL;T61
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62011-0058-31 in 1 BOX05/17/201203/30/2020
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:62011-0058-124 in 1 BOTTLE; Type 0: Not a Combination Product05/17/201203/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34805/17/201203/30/2020
Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 9/2019
 
Strategic Sourcing Services LLC