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Allergy by TOP CARE (Topco Associates LLC)

Medically reviewed on September 7, 2016

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: TOP CARE (Topco Associates LLC)
NDC Code: 36800-781

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 capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
    • sneezing
    • itchy, watery eyes
    • runny nose
    • 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
  • glaucoma
  • trouble urinating due to an 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
  • 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.

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 overtake 1 to 2 capsules 
children 6 to under 12 years of age take 1 capsule 
children under 6 years of age do not use 

Other information
  • store between 15-30ºC (59-86ºF)
  • protect from light

Inactive ingredients

butylparaben*, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, FD&C yellow #6*, gelatin, lactose*, lactose monohydrate*, magnesium stearate*, methylparaben*, polysorbate 80*, propylparaben*, purified water*, sodium lauryl sulphate*, starch

*contains one or more of these ingredients

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

MULTI-SYMPTOM

ALLERGY Capsules

Diphenhydramine HCl 25 mg Antihistamine

For Allergy Relief

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

Capsules

Each capsule individually banded for your protection

COMPARE TO BENADRYL® active ingredient**

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

DISTRIBUTED BY TOPCO ASSOICATES LLC

ELK GROVE VILLAGE, IL 60007

QUESTIONS? 1-888-423-0139

topcare@topco.com   www.topcarebrand.com

TAMPER EVIDENT: CAPSULE BANDED FOR YOUR PROTECTION. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

TopCare Multi-Symptom Allergy Capsules

ALLERGY 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-781
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN 
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
LACTOSE 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLPARABEN 
WATER 
SODIUM LAURYL SULFATE 
STARCH, CORN 
Product Characteristics
ColorPINK, WHITEScoreno score
ShapeCAPSULESize14mm
FlavorImprint CodeP25;CPC835
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-781-6224 BLISTER PACK in 1 CARTON
11 CAPSULE in 1 BLISTER PACK
2NDC:36800-781-781 BOTTLE, PLASTIC in 1 BOX
2100 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/15/2016
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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