ALLERGY RELIEF- diphenhydramine hydrochloride tablet 
TOP CARE (Topco Associates 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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DRUG FACTS

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the 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

  • 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 of 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)

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 take 1 to 2 tablets 
 children 6 to under 12 years of age take 1 tablet
 children under 6 years of age do not use 

Other information

  • each tablet contains: calcium 25 mg
  • store between 20-25°C (68-77°F)
  • protect from light and moisture

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, titanium dioxide

* contains one or more of these ingredients

Questions or comments?

Call toll free1-888-423-0139

Principal Display Panel

COMPLETE ALLERGY RELIEF

Allergy Relief Tablets

DIPHENHYDRAMINE HCl, 25 mg  ANTIHISTAMINE

For allergy relief

•Sneezing  •Runny Nose •Itchy,Watery Eyes •Itchy Nose & Throat

COMPARE TO BENADRYL® ALLERGY active ingredient**

TABLETS

**This product is not manufactured or distributed by McNeil Consumer Healthcare , Distributor of Benadryl® Allergy.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL  60007

1-888-423-0139 ©TOPCO  topcare@topco.com

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Diphenhydramine HCI 25 mg

TopCare Allergy Relief Tablets

ALLERGY RELIEF 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-690
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)  
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)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code T61;V25;S4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-690-363 in 1 CARTON03/31/201312/30/2020
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:36800-690-6224 in 1 CARTON03/31/201312/30/2020
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:36800-690-6748 in 1 CARTON03/31/201312/30/2020
31 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:36800-690-781 in 1 BOX03/31/201312/30/2020
4100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33603/31/201312/30/2020
Labeler - TOP CARE (Topco Associates LLC) (006935977)

Revised: 10/2019
 
TOP CARE (Topco Associates LLC)