DG HEALTH ALLERGY - diphenhydramine hydrochloride capsule 
Dolgencorp 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.

----------

Active ingredient (in each capsule)

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

Uses

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives

When using this product

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • 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

adults and children 12 years of age and over 1 or 2 capsules
children 6 to under 12 years of age 1 capsule
children 4 to under 6 years of age do not use unless directed by a doctor
children under 4 years of age do not use

Other information

Inactive ingredients

benzyl alcohol, butylparaben, D&C red no. 28, D&C yellow no. 10, edetate calcium disodium, edible ink, FD&C blue no. 1, FD&C blue no. 2, FD&C red no. 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide, sodium lauryl sulfate, sodium propionate

Questions or comments?

1-888-309-9030

Principal Display Panel

Compare to active ingredient of Benadryl® Allergy Kapseals®

Allergy Capsules

Diphenhydramine Hydrochloride

Antihistamine

For Allergy Relief

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

Easy to Swallow

Allergy Capsules Carton

Allergy Capsules Carton


DG HEALTH ALLERGY 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-462
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
BUTYLPARABEN 
D&C RED NO. 28 
D&C YELLOW NO. 10 
EDETATE CALCIUM DISODIUM 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
GELATIN 
LACTOSE 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLPARABEN 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
SODIUM PROPIONATE 
Product Characteristics
ColorPINK (clear) , WHITE (clear) , RED (band) Score no score
ShapeCAPSULESize14mm
FlavorImprint Code L462
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:55910-462-622 BLISTER PACK ( BLISTER PACK) in 1 CARTONcontains a BLISTER PACK
112 CAPSULE ( TABLET) in 1 BLISTER PACKThis package is contained within the CARTON (55910-462-62)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/22/2010

Labeler - Dolgencorp Inc (068331990)

Revised: 02/2010 Dolgencorp Inc