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Allergy Relief by TOP CARE (Topco Associates LLC)

Medically reviewed on December 28, 2017

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: TOP CARE (Topco Associates LLC)
NDC Code: 36800-690

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.

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

TopCare Allergy Relief Tablets

ALLERGY RELIEF 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-690
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
POLYSORBATE 80 
POLYVINYL ALCOHOL, UNSPECIFIED 
TALC 
TITANIUM DIOXIDE 
ALUMINUM OXIDE 
EGG PHOSPHOLIPIDS 
WATER 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize12mm
FlavorImprint CodeT61;V25;S4
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-690-363 BLISTER PACK in 1 CARTON
112 TABLET in 1 BLISTER PACK
2NDC:36800-690-6224 BLISTER PACK in 1 CARTON
21 TABLET in 1 BLISTER PACK
3NDC:36800-690-6748 BLISTER PACK in 1 CARTON
31 TABLET in 1 BLISTER PACK
4NDC:36800-690-781 BOTTLE, PLASTIC in 1 BOX
4100 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33603/31/2013
Labeler - TOP CARE (Topco Associates LLC) (006935977)

 
TOP CARE (Topco Associates LLC)

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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